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If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit ___ for more information. Brief Description: The Sleep Access and Reimbursement Manager (ARM) is responsible for executing the Oxybate market access business plan pertaining to the assigned geography, working with provider offices and outpatient care centers to ensure both providers and their staff are educated on payer and reimbursement policies and procedures, as well as providing expertise on the REMS program and patient support services. The ARM will work in collaboration with Field Sales, Sales Management, Patient Support Services, Managed Markets, Trade & Distribution, internal commercial teams, and other cross-functional partners to achieve the business unit objectives. The ARM will also develop relationships with all key personnel, targeted physicians, office managers, and staff vital to making Jazz's products accessible within key customer accounts. Provider and account interface, as well as billing and coding education within compliance, will be a key focus. This position will also play a critical role in ensuring REMS provider and patient enrollment, education on REMS process and requirements, and serve as an expert on patient support services. Essential Functions/Responsibilities * The ARM will implement strategies that achieve Business Unit and Corporate goals and objectives. * Analyze Data and develop Action Steps * Establish and maintain strategic relationships with assigned providers and provider accounts. * Educate and enhance awareness and utilization of patient access services, ensure providers understand payer prior authorization requirements and information, and educate offices on coding and billing * Serve as a field-based expert on the REMS program processes and procedures, including enrollment requirements for providers and patients. * Educate and inform provider offices on available patient services, collaborating and communicating with the Patient Access group and the Specialty Pharmacy to ensure optimal customer experience. * Collaborate and coordinate with area and regional sales teams to develop payer and reimbursement action plans for key provider accounts. * Monitor, document, and communicate coverage policy and changes. * Collaborate with internal and external partners to maintain a payer coverage and reimbursement database, and communicate changes to field sales and sales management teams. * Collaborates with Managed Markets to educate customers surrounding Commercial Payers, state Medicaid Agencies, Managed Medicaid Organizations, Healthcare Maintenance Organizations, Pharmacy Benefit Organizations, Health Care Plans, GPOs, DOD and Veterans Integrated Service Networks and other strategic healthcare entities specific to assigned initiatives and product requirements. * Conducts annual business development reviews for Jazz corporate and division management, as well as required updates and reviews with assigned area and regional sales team(s). * Provide managed care and reimbursement training and educational activities for internal and external stakeholders. * Remain current on key managed care, reimbursement, and policy activities, as well as serve as an expert for Jazz on business trends within key provider accounts. * Ensure all pertinent information regarding current products, new products, competitive data and overall information important to Jazz is brought to the attention of proper company personnel. * Represent Jazz at various industry functions such as payer and reimbursement meetings, payer policy meetings, professional organization meetings, and other meetings as assigned. * Demonstrates territory planning, priorities, and time management specific to geographical area of responsibility * Maintains accurate expenses within budget, timely and accurate completion of all reports, correspondence, and records as required by Jazz. * Execution of all activities within the defined Jazz regulatory and compliance program. * Maintain company manuals, reports, computer systems, records, brochures, computers and other equipment assigned to the position. #LI-Remote Required Knowledge, Skills, and Abilities * BA/BS Degree (MBA preferred), and at least 5 years of pharma, biopharmaceutical, and/or medical device experience calling on field based customers with demonstrated successful track record. * Account Management and/or Reimbursement experience working in the provider office setting, building strong customer relationships. * Experience working with HUB, Patient Services, and/or REMS programs * Experience working with Integrated Health Systems-- preferred * Managed Care and Reimbursement Knowledge --preferred * Experience in building a team atmosphere with sales representatives, either with direct or indirect leadership authority. * Ability to make sound decisions within time/resource constraints. * Proven skills in strategic decision-making and problem-solving. * Excellent analytical skills focusing on key accounts and uncovering business opportunities. * Experience working with billing and medical claims personnel in healthcare settings preferred. * Proficient with MS Office including Excel, Word, PowerPoint preferred * Candidates should live near a major airport and be willing and able to travel approximately 70-75% of the time (average 3-4 days per week). Required/Preferred Education and Licenses * BA/BS Degree (MBA preferred) * CPC, PAC or similar coding certification preferred, not require Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $148,000.00 - $222,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: ___.

R&D Scientist II – Materials / Polymer Focus (Lab-Based) - 626501 Location: Franklin Lakes, NJ (Onsite – 5 days/week) Duration: 12-month contract (W2) Pay Rate: ~$35.75 - $37.75/hr. Overview We are seeking a junior-level R&D Scientist II to join a Specimen Management R&D team, supporting the development of blood collection devices (e.g., tubes, needles, plastic components). This role is highly lab-focused (≈50%+ hands-on testing) and ideal for candidates with a background in materials science, polymer chemistry, or chemical engineering who enjoy bench work and experimental testing. Key Responsibilities • Conduct material characterization and testing, including:, • FTIR, DSC, TGA, rheology, and mechanical testing, • Environmental Stress Cracking (ESC) and Thermal Cycle Analysis (TCA), • Design and execute lab experiments and test protocols, • Perform root cause investigations related to material and product failures, • Support material selection, qualification, and vendor/material changes, • Prepare samples and prototypes for internal and external testing, • Document results and provide data-driven recommendations, • Assist with small-scale material assessments and innovation efforts, • Maintain lab equipment and follow Good Laboratory Practices (GLP), • Collaborate with cross-functional teams (R&D, Manufacturing, Quality, etc.), • Support testing involving human blood samples (training and PPE provided) Required Qualifications • Bachelor’s or Master’s degree in: Materials Science, Polymer Chemistry, Chemical Engineering, Mechanical Engineering, or related field, • 2+ years of laboratory experience (industry or academic), • Hands-on experience with materials testing and characterization, • Strong interest in polymer/material science (non-metal/ceramic focus), • Comfortable working in a lab-heavy, hands-on role, • Basic knowledge of statistical tools (Excel, Minitab, etc.), • Ability to conduct independent research and literature reviews Preferred Qualifications • Polymers or plastic materials (especially for medical devices), • Material formulation or modification, • ESC, TCA, or similar testing methods, • Exposure to analytical chemistry techniques, • Experience working with biological materials or blood samples, • Background in tissue engineering or DNA-related work (nice-to-have) Work Environment & Expectations • 50%+ lab-based work (testing, characterization, experimentation), • Remaining time focused on analysis, reporting, and innovation projects, • Fully onsite role (no remote option), • No travel required, • Dynamic, fast-paced R&D environment, • Opportunity for long-term growth Interview Process • Initial screening with Hiring Manager, • Follow-up panel interview with project team (virtual via Teams) Ideal Candidate Profile • Early-career scientist with a strong materials/polymer background, • Curious, hands-on, and eager to learn, • Comfortable working independently in a lab setting, • Interested in medical device R&D and material innovation

Position: Manufacturing Supervisor Department: Operations Reports to: VP of Operations & Quality Position Summary: The Manufacturing Supervisor is responsible for overseeing daily manufacturing operations to ensure production activities are completed safely, efficiently, and in compliance with company procedures and regulatory requirements. This role supervises manufacturing staff, coordinates production schedules, and works cross-functionally with Packaging, Engineering, and Quality to ensure consistent product output for gel-based medical device and OTC products. Key Responsibilities • Supervise and direct manufacturing staff to ensure production activities are completed on schedule and according to company policies and procedures., • Ensure the manufacturing team adheres to company SOPs, safety regulations, and regulatory requirements including FDA, cGMP, ISO 13485, MDD, and CMDR standards., • Coordinate production runs with the Packaging Department to ensure proper materials are available and production schedules are maintained., • Oversee the efficient and accurate manufacturing of core products, imprints, and special orders., • Participate in weekly production planning meetings and provide updates on manufacturing status and challenges., • Monitor production performance and prepare production reports as required, including adherence to the weekly production schedule., • Work with Engineering to support modifications, troubleshooting, and improvements to processing equipment and manufacturing processes., • Ensure manufacturing documentation is completed accurately and in accordance with quality system requirements., • Maintain a safe, clean, and organized production environment., • Support training of manufacturing staff and participate in internal training initiatives., • Complete special projects and operational initiatives as assigned by management. Skills & Competencies • Strong leadership and supervisory skills with the ability to motivate and guide teams, • Excellent interpersonal and communication skills, • Ability to enforce policies and procedures while maintaining positive team relationships, • Strong organizational and problem-solving abilities, • Detail-oriented with a strong focus on quality and compliance, • Ability to manage multiple priorities in a fast-paced manufacturing environment, • Team-oriented with strong collaboration skills, • Proficiency in Microsoft Office applications Qualifications • Minimum of 3 years of supervisory experience in a manufacturing environment, • Experience working in regulated manufacturing environments (medical device, pharmaceutical, cosmetics, or similar industries preferred), • Bachelor’s degree in a technical or engineering-related field preferred, • Knowledge of cGMP, FDA regulations, and ISO 13485 standards preferred, • Experience with production scheduling and manufacturing reporting Work Environment • This role operates primarily in a manufacturing environment and requires regular interaction with production and packaging personnel, engineering staff, and quality teams.

(Senior) Director, CMC QA – Permanent – New York Proclinical is seeking a (Senior) Director, CMC Quality Assurance for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The (Senior) Director, CMC QA will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Immediate need for a talented Lab Facilities Specialist - III (Senior). This is a 06+months contract opportunity with long-term potential and is located in Rahway, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 26-09532 Pay Range: $36/hr - $36.40/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: • Note: Shift: 7.30am-4pm EST., • 100% Onsite Role., • Associate Specialist, Laboratory Operations – Device Development & Technology, • The greatest inventions would not be brought to market without the right project management and operations/administrative support., • Woven into every part of CLIENT Research Laboratories (MRL), our operations/administrative team ensures that our R&D concepts become a reality for patients worldwide., • The MRL Device Development & Technology (DD&T) Organization within Pharmaceutical Sciences & Global Clinical Supply (PSCS) is seeking a highly motivated, Associate Specialist to support laboratory operations., • The position is an in-person position, operating from our Rahway, New Jersey site., • This position will receive day-to-day responsibilities from the Senior Specialist, Laboratory Operations Management – Device & Combination Product development., • Coordinate and perform general laboratory administrative duties including, but not limited to, maintaining testing, calibration and equipment maintenance scheduling, ordering routine & specialty supplies, and facilities management., • Maintain development and GXP laboratory equipment and instrumentation in accordance with internal and industry best-practices/standards., • Coordinate laboratory technical & safety training, including documentation lifecycle management., • Collaborate with key internal & external (outside DD&T) stakeholders to coordinate/arrange new vendor technology evaluations., • Support team with laboratory procurement needs including purchase orders, invoice payments and expense tracking., • Support team with domestic and international shipping of equipment (testing & manufacturing) and product samples (drug & combination product)., • Extraordinary attention to detail, independent judgement, and the ability to prioritize and execute work activities with minimal supervision., • Ability to interact professionally with internal and external colleagues both on-site and remotely to maintain laboratory workflows & operations. Key Requirements and Technology Experience: • Key skills; "calibration", "lab", “calibrate”, "troubleshoot", • Must be able to lift, box, and unbox up to 45 lbs unassisted, • Must be able to move pallets using a pallet jack., • Must be able to walk(5-10miles) everyday, sit and stand for longer duration., • Able to drive golf cart., • Have a valid driver's licence., • High School Diploma, • Minimum 2 years of relevant exeprience. Metrology exeprience preferred., • Advanced computer skills using MS Outlook, Teams, Project, SharePoint, Word, Excel, PowerPoint and Adobe., • Experience in device and combination product characterization & mechanical testing is highly preferred., • Experience in GXP-Analytical laboratory testing or management is highly preferred., • SAP/Concur or related system experience processing purchase orders (PO), expense reports, payment requests, vendor add forms, as well as stockroom inventory reports. Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy ___.

Job Description Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals. The Engineering Specialist will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level. Location: Onsite Job Description Major accountabilities: • Adhere to Novartis Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality., • Perform a wide range of maintenance repair activities on production equipment, lab equipment and building management systems., • Provide guidance and leadership to team members., • Assist in troubleshooting and repair of process equipment (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision., • Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs., • Support 24x7 site-based operations after startup., • Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems., • Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment, • Completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System, • Supply information and technical data for securing spare parts., • Provide responsive customer support with emphasis on customer satisfaction., • Perform startup and commissioning activities as required., • Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs, • Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment., • Complete and provide accurate documentation, as required in cGMP operations., • Oversee work and provide training of less experienced maintenance technicians and/or new technicians., • Other related duties as assigned., • Use of CMMS system for documentation of relevant work. The salary for this position is expected to range between $85,400 and $158,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Minimum Requirements: • High School diploma or equivalent is required; bachelor's degree is preferred., • 3+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required., • Previous supervisory, team/project lead experience is preferred., • Previous aseptic fill/finish and/or radio pharmacy experience is preferred., • Previous pharmaceutical or medical device experience is preferred., • Completed training in radioactive or hazardous materials environment is preferred., • Must be able to adhere to all applicable procedures, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.), • Experience working in a team environment, with excellent communication and organizational skills., • Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) or similar system., • Ability to climb ladders and lift up to 50 lbs., • Wear and work in protective clothing, including respiratory protection, confined space entry and clean room environments., • Must be flexible to work nights, weekends, and holidays as required. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $85,400.00 - $158,600.00 Skills Desired Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems, Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Director of Global Supply Network Excellence. The Quality & Compliance Director is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across QuidelOrtho' s overall supply network providing leadership for supplier quality and supply chain quality -ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The role partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement. The role leads the strategy for quality support of end-to-end supply chain. Encompassing distribution, marketing companies and supplier management. The responsibilities span all quality elements associated with the supplier management process including initial partner selection, creation and maintenance of quality agreements, monitoring of overall partner organization quality performance, supplier audit, change management and non-conformance / CAPA oversight. This position includes the oversight of the purchasing control processes. This role also demands identification and execution of continuous improvements to QuidelOrtho' s Supplier Quality Management processes at the global level to meet the current and future needs of the QuidelOrtho business. These improvements will ensure continued compliance with quality system regulations while driving overall efficiencies and improvements in QuidelOrtho' s Supplier Quality Management Processes. These initiatives will demand close collaboration with key stakeholders and business partners across the organization including but not limited to Global Procurement, Global Supply Chain, Operations, R&D, Site Quality, Design Quality, Global Compliance and Regulatory. This leader is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Quality & Compliance Manager/Senior Manager ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be onsite in Rochester, NY or San Diego, CA. * Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives. * Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. * Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. * Management Responsibility as required by ISO13485/9001 and ensuring specific economic operator roles are fulfilled - for example, importer / distributor / Authorized Representative responsibilities * Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. * Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle. * Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). * Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. * Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements. * Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning. * Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders. * Manage departmental budget and resources effectively, identifying opportunities to drive cost efficiencies while maintaining compliance and quality standards. * Model QuidelOrtho' s leadership principles by demonstrating collaboration, accountability, inclusion, and service mindset in all interactions. * Person Responsible for Regulatory Compliance (PRRC per EU IVDR (2017/746) on behalf of the wholly-owned legal manufacturers of QuidelOrtho Corporation as defined in the Delegation of Authority (DMS-POL80064) * Article 15(3)(a): Responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. * Execution of Importer and distributor responsibilities, specially making sure that the devices placed on the market bear the CE marking, are accompanied by the required information and labelled in accordance with the Regulation, and storage and transport conditions are in line with specifications. * Perform other work-related duties as assigned. Required: * Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required.12+ years' experience in Medical Device quality system management * Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR * Experience/knowledge of Supplier Quality Management Processes, auditing, Change Management, Root Cause Analyses, Corrective/Preventive Actions * Experience/knowledge with distribution processes, logistics and supply chain operations * Proven ability to lead and develop high-performing teams and build future technical and people leaders. * Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. * Excellent collaboration, influence, and communication skills across functional and organizational boundaries. * Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement. * Experience leading in a matrixed, global organization and managing competing priorities effectively. * Commitment to scientific integrity, compliance excellence, and continuous improvement Preferred: * Desirable certifications include ASQ -CQA, ASQ-CQE, ASQ-SWQE, ASQ-CQM, * Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. * Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools. * Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, and other Quality & Compliance teams globally and regionally External: Suppliers/External Manufacturers: In line with established Quality Agreements ensure partnership with External Partner sites to monitor and improve quality performance The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $249,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for assembling products and recording required information to meet production requirements and quality standards. Contribute to the operation of the production area, and ensure compliance with GMP, GDP, ISO, ESD, and all other regulatory requirements. Job Responsibilities and Essential Duties • Understand and adhere to safety policies and practices, • Understands and follows all Getinge and site-specific policies and procedures., • Builds product by following all processes in which trained (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics., • Demonstrated ability to follow and implement GMP, GDP, ESD and all other applicable regulatory requirements, • Full understanding of document control procedures, • Ability to use basic test and measurement equipment, • Demonstrate an understanding of the basic functions of SAP, if applicable, • Determine if components and/or assemblies meet specification and reject if necessary. Escalate issues to Manager as necessary., • Maintain accurate records, including shop floor paperwork (SFP), • Ability to work independently, or as part of a group, and display a high quality of skill in both mechanical and electronic assembly with a minimum of supervision. Minimum Requirements • High School diploma or equivalent, or 3+ years of work experience required., • Medical device or other regulated manufacturing environment experience preferred but not required, • Electromechanical assembly experience required, • Must have basic computer skills, SAP experience a plus, • Must be able to work in a team environment Required Knowledge, Skills, and Abilities • Knowledge of and ability to use basic small hand tools and power tools, • Knowledge of and ability to use basic test and measurement equipment, • Must have good oral and written communication skills Pay Range: $18.50- $19.80 /hr. #LI-BS1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. * Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. * Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. * Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. * Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. * Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. * Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. * Perform other work-related duties as assigned. Required: * Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. * 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. * Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. * Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. * Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. * Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. * Bias toward action, with a track record of driving execution aligned to organizational strategy. * Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. * Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. * Willingness and ability to travel approximately 10-15%. Preferred: * Advanced degree (MS, PhD, or PharmD) strongly preferred. * Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. * Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. * Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for assembling products and recording required information to meet production requirements and quality standards. Contribute to the operation of the production area, and ensure compliance with GMP, GDP, ISO, ESD, and all other regulatory requirements. Job Responsibilities and Essential Duties • Understand and adhere to safety policies and practices, • Understands and follows all Getinge and site-specific policies and procedures., • Builds product by following all processes in which trained (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics., • Demonstrated ability to follow and implement GMP, GDP, ESD and all other applicable regulatory requirements, • Full understanding of document control procedures, • Ability to use basic test and measurement equipment, • Demonstrate an understanding of the basic functions of SAP, if applicable, • Determine if components and/or assemblies meet specification and reject if necessary., • Escalate issues to manager as necessary., • Maintain accurate records, including shop floor paperwork (SFP) Minimum Requirements • High School diploma or equivalent, or 3+ years of work experience required., • Medical device or other regulated manufacturing environment experience preferred but not required, • Must have basic computer skills, SAP experience a plus, • Must be able to work in a team environment Required Knowledge, Skills, and Abilities • Knowledge of and ability to use basic small hand tools and power tools, • Knowledge of and ability to use basic test and measurement equipment, • Must have good oral and written communication skills About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Axelon Services Corporation - - Responsibilities: Produce high-quality medical devices within a manufacturing cell; Perform assembly, repair, and test operations on pacemakers, ICDs, leads, and related medical device assemblies under close supervision; Ensure relevant job documentation for cell ope

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for processing incoming materials including kitting/picking for production needs. Knowledge of all related procedures. Position will also include cycle counting, shipping, warehouse, and mailroom responsibilities. Job Responsibilities and Essential Duties • Receiving, and incoming materials processing, • Inspect & pack (lot preparation) according to specific procedures., • Distribute components and supplies to Manufacturing., • Perform all transactions according to procedures., • Perform mail services such as pickup/drop off at Post Office, sorting, delivery within building, and maintenance and service of postal machine., • Pack Items to be shipped., • Inventory control and cycle counting., • Handle chemicals and hazardous waste per procedure., • Handle and deliver customer complaint items., • This is not an inclusive list of job responsibilities. Minimum Requirements • High School Diploma or equivalent is required., • Minimum 1-year prior experience working in a warehouse or distribution center is preferred., • Open to working the 1st shift (7AM - 3:30PM). There is some potential flexibility on hours, • Experience working in a regulated environment such as medical device, aerospace, pharmaceutical, etc. is preferred Required Knowledge, Skills, and Abilities • SAP or other ERP software knowledge preferred., • Basic proficiency with Microsoft Office or equivalent software application is preferred., • Must have a valid drivers' license. This is a "Defined Term" assignment that will last approximately 12 months or until project is complete. Defined Term employees areeligible for mostbenefits (including health insurance and paid time off) while on assignment. Pay range: $19.80 - $23.00 / hour #LI-BS1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Sr. Quality Product Data Specialist will serve as the subject matter expert for product data supporting the global product ship hold and field action processes for Getinge within the Global Services organization. This is a defined -term (fixed term) position for 24 months, directly hired with Getinge. Job Responsibilities and Essential Duties • Collaborate effectively with all entities (businesses) across Getinge and serve as subject matter expert for the Getinge global product ship hold process., • Extract, analyze, and validate product data from Getinge ERP system (SAP) to support field actions, investigations, audits and other quality activities., • Lead and/or participate on cross functional project teams to identify and implement solutions for identified issues related to product data and associated topics., • Collaborate with internal teams, including regulatory, quality, manufacturing, and customer service, to gather data and ensure accurate product data flow and documentation through all aspects of the field action process., • Provide input for and/or review departmental procedures, work instructions, templates, and guidance related to product data., • Provide support for internal and external audits., • Stay current on changes in SAP functionality and best practices related to field actions and product data, incorporating these into the company's processes and procedures., • Bachelor's degree in scientific, technical, or information based discipline or equivalent work experience., • A minimum of 5 years of experience in technical, operations or data focused role using SAP as a core system. Experience in medical device or pharmaceutical industry preferred., • Must have general understanding of product data structures and hierarchy models, • Must have general understanding of reporting tools, • Strong analytical and problem solving skills with demonstrated ability to analyze complex data sets, identify trends and present actionable findings, • Detail oriented, highly organized, and performs work with a high degree of accuracy, • Strong ability to multi-task and handle various initiatives that take place simultaneously, • Must demonstrate effective written and verbal communication, including technical writing skills, • Proficiency with Microsoft Office Suite (Word, Excel, Outlook, Teams, SharePoint, PowerPoint) #LI-JF1 #LI-remote The salary range for this position is a minimum of $106,000/annual and a maximum of $132,000/annual. About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The primary purpose of this position is to lead, develop, establish, and maintain quality engineering policies, processes, procedures and controls ensuring that design, development, performance and quality of products conform to internal specifications and established standards. Coordinates with stakeholders in R&D and Manufacturing to assure design quality and accuracy in both new and sustaining product development. Responsible to manage and maintain product Risk Files. Leads Health Hazard Evaluations (HHEs) to help assess product performance risk to enable appropriate Field Action decisions. Maintains oversight and upkeep of Field Action Plans. Job Responsibilities and Essential Duties • Define, maintain, and revise processes, and QMS procedures to ensure company and products comply with applicable regulations and laws. Specifically for Design Controls, Risk Management, HHE, Field Actions and Test Method Validations., • Provide guidance throughout product development lifecycle focusing on areas of Design Controls and Risk Management, ensuring compliance to 21 CFR 820 and ISO 13485., • Review Design Input, Output and verification artefacts to ensure Customer Requirements are translated to feasible technical solutions with an acceptable risk., • Provide quality oversight during new product development (NPD) and design changes, ensuring risk-based decision-making., • Support design verification and validation (V&V) activities, including test method validation, failure investigations, and nonconformance resolution. Oversee validation of software used in medical devices (embedded, standalone, SaMD). Review and approve software validation, • plans, protocols, and reports to ensure regulatory compliance and product safety. Work with cross-functional teams to assess the impact of software changes, patches, and updates on device safety and performance., • Support and Lead (when appropriate) product quality investigations, driving root cause analysis and corrective actions., • Provide support to project teams in the use of data analysis tools such as DFSS and DOE. Lead effort in data driven decision making activities., • Establish, implement, and maintain a comprehensive Risk Management process in accordance with ISO 14971 and global regulatory requirements., • Own and manage product risk files, ensuring continuous updates throughout the product lifecycle., • Partner with R&D and Regulatory teams to ensure risk-benefit analysis aligns with regulatory submissions and post-market feedback., • Drive Failure Modes and Effects Analysis (FMEA) sessions to proactively identify and mitigate design, process, and use-related risks., • Lead the Health Hazard Evaluation (HHE) process, ensuring thorough risk assessment for field issues, complaints, and potential recalls., • Drive decision-making for field actions, including recalls, corrections, and removals, in compliance with global regulatory expectations., • Work cross-functionally with Regulatory, Medical Affairs, and Legal teams to develop risk mitigation strategies and regulatory submissions for field actions., • Support internal and external audits, including FDA, Notified Body, and MDSAP audits, ensuring a state of continuous inspection readiness., • Monitor the effectiveness of document control & records control processes are developed and maintained., • Establish quality metrics and KPIs (for processed under assigned responsibility) to track product/process performance and effectiveness of quality initiatives (when applicable)., • Identify and lead continuous improvement projects and CAPAs and HHE's. Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate., • Ensure that the conformity of the devices is appropriately checked, in accordance with the Quality Management System under which the devices are manufactured, before a device is released to comply with Article 15 of European Union Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745 of the European Parliament and of the council of 05 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC)., • Collaborate with post-market surveillance teams to assess field performance and identify opportunities for product improvements., • Support post-market surveillance activities to ensure compliance with Article 10(10) of European Union Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745 of the European Parliament and of the council of 05 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC). Ensure any new risks identified in this effort are reflected in the Risk Management File in a timely manner. ___Minimum Requirements • Bachelor's Degree in Science or Engineering or equivalent combination of education and experience., • A Master's of Science in Engineering, Science or related field is preferred., • A minimum of 7 years' experience in design controls, related experience in QA in a Medical Device manufacturing environment. Sterile disposable experience a plus., • Knowledge of process, equipment and software validation., • Previous background and experience in Quality Assurance and Manufacturing., • Strong knowledge and experience in 21 CFR part 820, ISO 13485 and other related regulatory requirements., • Successful interactions and experience with regulatory agencies., • Good knowledge of statistics and practical application of the QSR and ISO 13485. Required Knowledge, Skills and Abilities • Solid Project Management and Leadership experience is required., • Experience in FDA regulated industry or ISO certified organization., • Demonstrated proficiency in Statistical analysis, ability to analyze and solve complex problems, proficient with analytical software applications and the ability to communicate effectively across departments, with R&D and Manufacturing., • Experience in design controls, sustaining engineering, and post-market surveillance., • Experience in risk management, including FMEA and maintaining product risk files., • Strong problem-solving skills with experience in root cause analysis and CAPA., • Experience with regulatory audits and inspections (FDA, Notified Body, MDSAP, etc.), • Strong knowledge of ISO 13485, FDA 21 CFR Part 820, 21 CFR 806, ISO 14971, IEC 62304, MDR 2017/745, and other global regulatory requirements., • Experience with sterile and electro-mechanical medical devices, including applicable standards (ISO 11135, ISO11607-1, IEC 60601)., • Experience in conducting and participating in FDA/Customer/corporate audits., • Excellent leadership, communication, and cross-functional collaboration skills., • Proficiency in using tools like MINITAB, SAP or equivalent software applications. Salary Range: $140-165k plus 15% bonus (depending on overall company performance) #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for the planning, procurement, and management of raw material and CMO products to ensure manufacturing commitments are achieved while supporting inventory and sales objectives. Represents the company professionally and ethically as a purchasing agent. Job Responsibilities and Essential Duties • Evaluate MRP to procure and schedule raw materials and CMO products in accordance with procedures., • Provide timely and appropriate material availability information to internal customers., • Establish and maintain supplier relationships; take corrective action as appropriate., • Align inventory with plant objectives and targets., • Participate in projects, continuous improvement initiatives, and product introductions as assigned., • Maintain SAP parameters to ensure data integrity., • Resolve receiving discrepancies, invoices, and supplier returns., • Work closely with internal customers to communicate and follow up on issues related to purchased goods and services. Minimum Requirements • A Bachelor's degree in Business Management or related field, or a combination of education and related experience., • 2-3 years of experience in purchasing, materials management, production planning, or similar fields., • Must demonstrate effective verbal and written communication skills., • Must demonstrate ability to exercise sound judgment, be well organized, take initiative, be flexible, • Must work well under pressure, work effectively with both employee and management and be able to facilitate resolution of complex issues., • Demonstrated ability to apply sound procurement practices and principles and provide solutions to procurement and purchasing issues., • Previous working knowledge of MRP or equivalent system is preferred., • Prior SAP experience is preferred Salary range: $80k - $85 #LI-AL1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for assembling products and recording required information to meet production requirements and quality standards. Contribute to the operation of the production area, and ensure compliance with GMP, GDP, ISO, ESD, and all other regulatory requirements. Job Responsibilities and Essential Duties • Understand and adhere to safety policies and practices, • Understands and follows all Getinge and site-specific policies and procedures., • Builds product by following all processes in which trained (in their most current revision), and completing other assigned work, while meeting manufacturing goals and metrics., • Demonstrated ability to follow and implement GMP, GDP, ESD and all other applicable regulatory requirements, • Full understanding of document control procedures, • Ability to use basic test and measurement equipment, • Demonstrate an understanding of the basic functions of SAP, if applicable, • Determine if components and/or assemblies meet specification and reject if necessary., • Escalate issues to manager as necessary., • Maintain accurate records, including shop floor paperwork (SFP), • Ability to work independently, or as part of a group, and display a high quality of skill in both mechanical and electronic assembly with a minimum of supervision. Minimum Requirements • High School diploma or equivalent, or 3+ years of work experience required, • Some electromechanical assembly experience required, • Medical device or other regulated manufacturing environment experience preferred but not required, • Must have basic computer skills, SAP experience a plus, • Must be able to work in a team environment, • Understand this is a defined term position that will go about 12 months Required Knowledge, Skills, and Abilities • Knowledge of and ability to use basic small hand tools and power tools, • Knowledge of and ability to use basic test and measurement equipment, • Must have good oral and written communication skills Pay Rate: $18.50 - $19.80 / hour #LI-BS1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview: This position performs installation, maintenance, and repairs of computer driven electro-mechanical production equipment, ensuring that all related quality documentation is executed, while reviewing maintenance procedures for effectiveness. Job Responsibilities and Essential Duties: • Maintenance and repair of computer driven electro-mechanical manufacturing equipment in support of medical device production. o Computer driven systems include proportional-integral-derivative (PID) operating controllers, programmable logic controllers (PLCs), and Human Machine Interface (HMI) automation. o Sub-systems and components include electric drives, motors, electrical wiring, hydraulics, pneumatics, electrical panels, relays, printed circuit board circuitry, vacuum, and compressed air. • Respond to emergency repair requests through troubleshooting, diagnosis, resumption of operation, and electronic documentation., • Execute preventative/scheduled maintenance including planning of materials, parts, training, and other requirements to ensure work is executed in an efficient and timely manner., • Document all work planned and performed in the computerized maintenance management system., • Evaluate operation of equipment and instruments to conduct on-line adjustments. * Evaluate, quote, and order necessary replacement equipment, tools, and fixtures. * May develop or revise documents and procedures., • Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Minimum Requirements : • A high school diploma or equivalent is required. An associate degree or equivalent years of experience in Engineering, Science or related technical field is preferred, • 1-3 years of technician experience in a manufacturing environment is required; experience working in medical device manufacturing or other FDA regulated industry preferred. Required Knowledge, Skills, and Abilities : • Ability to read wiring diagrams, schematics, and plumbing diagrams to expertly troubleshoot electro-mechanical equipment, electric drives, motors, basic wiring, hydraulics, and pneumatics is required., • Working knowledge of flow controls, valve selection, and pressure regulation., • Must demonstrate effective verbal and written communication skills., • Must be well organized and demonstrate the ability to work independently and manage multiple tasks and priorities., • Must be flexible and demonstrate the ability to take initiative., • Working knowledge of equipment powered by 120, 208/230, and 480VAC electrical voltage is required., • Experience with PLC/HMI and MS-DOS programming languages is preferred., • Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred. The pay for this role is a minimum of $25 per hour ($52k/yr) and a maximum of $33 per hour ($68,640/yr). About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Medical Device Manufacturing Company.Demand & Supply Chain Planning - Analyst 2.This is for an initial duration of.Job Title: Demand & Supply Chain Planning - Analyst 2.Position Type: Hourly Contract Position (W2 only).Typically, onsite days are Monday-Thursday, with Friday's working from ho

This Jobot Job is hosted by: Ryan Weingardt Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $85,000 - $115,000 per year A bit about us: A century-old, privately held contract manufacturer specializing in medical device components and assemblies. Headquartered in Butler, Wisconsin, it operates additional facilities in Hudson, New Hampshire, and Largo, Florida. The company is renowned for its expertise in silicone molding, thermoplastics, and multi-material molding, serving some of the world's largest medical device companies. Their capabilities encompass design assistance, development, manufacturing, and finished device assembly, all conducted within ISO-certified cleanroom environments Why join us? The company offers a competitive compensation package, including health, dental, and vision insurance, life and disability benefits, a 401(k) plan, and quarterly profit-sharing bonuses. They emphasize employee development through mentoring, continuing education, and exposure to the latest technological advances in the medical device field. Job Details Position Summary: The Process Engineer will play a critical role in supporting and optimizing the company’s molding operations. Based at the Brookfield, WI headquarters, this position will focus on a variety of molding technologies including injection molding, compression/transfer molding, liquid silicone rubber (LSR), thermoplastics, and high-consistency rubber (HCR). The ideal candidate will apply scientific molding principles to improve process reliability and performance, support mold qualifications, and lead continuous improvement initiatives. Key Responsibilities: • Develop, implement, and optimize molding processes using scientific molding techniques., • Perform initial mold setups and troubleshoot tooling and process issues., • Collaborate with cross-functional teams to support new product introductions and mold validations., • Analyze process data to identify trends and implement corrective actions., • Train and mentor process technicians and production staff on best practices and process controls., • Minimum of 5 years of hands-on experience in molding process engineering, preferably in a medical device manufacturing environment., • In-depth knowledge of injection molding, LSR, thermoplastics, and HCR processes., • Experience with scientific molding methodologies and DOE (Design of Experiments) is strongly preferred., • Technical degree in engineering or a related discipline is preferred., • Strong problem-solving skills, attention to detail, and a commitment to continuous improvement. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Job Description Summary The Territory Account Leader is responsible for driving revenue growth and strategic account development across the pharmaceutical, medical device and CDMO industry in North America while leading a team of Territory Account Managers. This role leads territory sales activities focused on prefilled syringe platforms while strategically positioning the company's broader portfolio of drug delivery devices (ADDS), combination product solutions, and laboratory services. The Sales Manager develops deep partnerships with pharmaceutical customers, identifies opportunities across the drug lifecycle, and collaborates with internal cross-functional team members to deliver integrated solutions that support successful drug development and commercialization. This role requires strong consultative selling capabilities, deep knowledge of the injectable drug delivery landscape, and the ability to engage with cross-functional stakeholders including R&D, quality, regulatory, and procurement within target accounts. This position will report to the Vice President of Sales - Regional Accounts North America Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Territory & Account Leadership * Develop and execute a territory strategy to grow sales of prefilled syringe platforms and related drug delivery solutions across Services and ADDS. * Manage and expand territory accounts across the assigned NA territory. * Build long-term strategic relationships with decision makers across technical, development, and commercial functions. * Identify opportunities early in drug development pipelines to position BD products and combination product solutions. * Ensure BD Management is kept abreast of the customer's industry and business environment, including the presence/threat of competition, in order to formulate proactive strategies to increase BD's share of category * Responsible for 3-5 year Territory outlook and strategic objectives Strategic Solution Selling * Lead consultative sales engagements that position integrated offerings including prefilled syringe platforms, injection device technologies, combination product development services, and analytical/testing laboratory services. * Collaborate with internal technical teams to develop customized customer solutions. * Translate customer development challenges into opportunities for the company's device and service capabilities. * Directs the account manager team to maintain a high level of responsiveness and issue resolution in order to drive greater customer satisfaction and loyalty Pipeline Development & Opportunity Management * Build and manage a strong pipeline of development and commercial opportunities. * Drive opportunities from early development through commercialization. * Utilize CRM tools (sf.com, financial databases, etc) to track pipeline, forecasts, and customer engagement. Cross-Functional Collaboration * Maintain a robust internal network of cross-functional contacts to maximize information flow and proactively communicate critical information within the BD network * Coordinate internal resources to deliver high-impact technical engagements and proposals. Market Intelligence * Maintain understanding of injectable drug delivery trends, combination product regulations, and competitive technologies * Provide feedback to internal teams including sales, marketing, platform and leadership on customer needs and market opportunities. Revenue & Performance * Achieve and exceed territory revenue targets. * Develop strategic account plans for key customers. * Deliver accurate sales forecasting and pipeline visibility in coordination with supply chain and customer service. * Maintain and control expenses in line with company guidelines and annual budget * Participate in trade associations and industry conferences as deemed necessary to drive account objectives and/or recommended by BD management * Support special project initiatives as assigned At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role: * Annual Bonus * Potential Discretionary LTI Bonus Health and Well-being Benefits * Medical coverage * Health Savings Accounts * Flexible Spending Accounts * Dental coverage * Vision coverage * Hospital Care Insurance * Critical Illness Insurance * Accidental Injury Insurance * Life and AD&D insurance * Short-term disability coverage * Long-term disability insurance * Long-term care with life insurance Other Well-being Resources * Anxiety management program * Wellness incentives * Sleep improvement program * Diabetes management program * Virtual physical therapy * Emotional/mental health support programs * Weight management programs * Gastrointestinal health program * Substance use management program * Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit Retirement and Financial Well-being * BD 401(k) Plan * BD Deferred Compensation and Restoration Plan * 529 College Savings Plan * Financial counseling * Baxter Credit Union (BCU) * Daily Pay * College financial aid and application guidance Life Balance Programs * Paid time off (PTO), including all required State leaves * Educational assistance/tuition reimbursement * MetLife Legal Plan * Group auto and home insurance * Pet insurance * Commuter benefits * Discounts on products and services * Academic Achievement Scholarship * Service Recognition Awards * Employer matching donation * Workplace accommodations Other Life Balance Programs * Adoption assistance * Backup day care and eldercare * Support for neurodivergent adults, children, and caregivers * Caregiving assistance for elderly and special needs individuals * Employee Assistance Program (EAP) * Paid Parental Leave * Support for fertility, birthing, postpartum, and age-related hormonal changes Leave Programs * Bereavement leaves * Military leave * Personal leave * Family and Medical Leave (FML) * Jury and Witness Duty Leave At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Your career at BD () . Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $146,076.92 - $233,723.08 At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Our company's DD&T Team is seeking a hands-on medical device product manufacturing and assembly engineer. Mechanical Engineering (or related field) with 10+ years of regulated industry experience and increasing responsibility in medical devices and/or drug-device combination products. Strong interpe

Quality Systems Director – Permanent – New York Proclinical is seeking a Quality Systems Director for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The Quality Systems Director will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Job Description Our client in Fairfield, NJ is looking for a Senior Product Release Engineer for a Full time position. Pay is $110-125k annually DOE Responsibilities: • Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements., • Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs., • Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes., • Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities., • Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities., • Understand and meet Regulatory (FDA) requirements and processes for development., • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s., • Bachelor’s degree in mechanical engineering or biomedical engineering., • Minimum of 10 years of medical device experience., • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products., • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description ABOUT ORGANOX: OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. About the Role We are seeking a dynamic Product Manager, Downstream to drive the commercial success and market adoption of the OrganOx metra, normothermic perfusion platform. This role is focused on translating complex clinical and economic data into compelling messaging and tools that resonate with customers, support the sales team, and ensure top-line growth. You will become the clinical and functional expert on the metra, working closely with sales, clinical affairs, and key customers to shape market perception and drive share growth. The role will require development of customer and field facing strategies, market research to understand market trends and customer insights, clinical evidence strategy, and support of continuation marketing activities. To gain deep clinical and technical product knowledge the Product Manager, Downstream will be expected to spend time with customers and sales team regularly. This person will also work closely with cross-functional partners across the organization and should have the ability to lead and work with a diverse range of partners and on multiple parallel projects. Requirements • Commercialization & Go-to-Market: Lead end-to-end launch planning and execution for new products and existing product updates across global markets, ensuring operational readiness of supply chain, manufacturing, and sales., • Product Positioning & Messaging: Develop and refine product positioning, value proposition, and messaging tailored to specific customer segments (e.g., transplant physicians, hospital and transplant service line administration, patients, patient advocacy groups) and regional markets., • Sales Enablement and Training: Develop high-impact sales tools, training materials, and programs to equip field teams with the resources needed to elevate customer conversations and overcome objections., • Clinical and Economic Evidence Communication: Translate complex clinical study data and economic evidence into clear, compelling stories and tools that demonstrate the product's differentiated value and link outcomes, cost, and long-term clinical benefit., • Market and Competitive Intelligence: Monitor market dynamics, track competitor activity, and gather customer feedback to inform marketing strategies and develop comprehensive competitive response plans., • Stakeholder and KOL Engagement: Build and maintain strong relationships with Key Opinion Leaders (KOLs) and customers through field visits, scientific meetings, and educational programs to gain insights and drive market adoption. · Education: Bachelor's degree required; MBA or advanced degree preferred. · Experience: Minimum 3 years of experience in product management or marketing within the medical device industry, with a strong emphasis on downstream or commercial marketing. · Clinical Knowledge: Ability to gain deep clinical and technical product knowledge and serve as a subject matter expert to internal and external stakeholders. · Communication Skills: Excellent interpersonal, written, verbal, and presentation skills, with proven experience presenting to senior leadership and external customers. · Cross-functional Collaboration: Demonstrated success working as an integral cross-functional team member, capable of influencing without direct authority. Experience with regulatory approval processes for medical device systems, including electronics and software. · Analytical Skills: Strong analytical and data interpretation skills to track performance, analyze sales trends, and make data-driven decisions. Proven ability to collaborate with commercial and finance teams to define and implement effective business models. · Travel: Ability to travel up to 25-30% of the time, including field visits and industry events. · Preferred Qualifications · Direct experience with medical devices or pharmaceuticals supporting the transplant market. · Proven track record in launching products into new or existing markets. Benefits We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME) and Project Manager in the execution of Cresilon’s Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. This position as a hybrid role, with work off-site at CRO in NY/NJ area, work from home and on-site at Brooklyn NY. Job Responsibilities: The Preclinical Research Scientist will: • Lead, staff, and manage Cresilon’s Preclinical Research activities., • Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life=cycle., • Plan, direct, coordinate, and execute activities related to the design, initiation. and follow-up of studies to support approval of Class I-III medical devices., • Develop, write, and/or review study protocols and repor-s. Act as a technical mentor for the development of study experimental designs, protocols, and reports of junior associates., • Administrate and manage Cresilon's preclinical regulatory strategy and communication., • Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites., • Ensure that the company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon., • Be a Subject Matter Expert (SME) for the preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state-of-the-art knowledge., • Oversee the development of and modifications to preclinical models to address project needs., • Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines., • Surveys the literature to identify and compare competitive product performance and safety risks., • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc), • Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary., • Manage budgetary requirements for all research projects to support efficacy and safety programs., • Lead the effort to publish surgical research in peer-reviewed journals., • Regularly interface with management to ensure research operations reflect overall corporate vision/strategy., • DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience., • 4+ years of people management experience preferred., • Extensive knowledge of surgery, anatomy, toxicology, and pathology is required. Hands-on surgical experience is require., • Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred., • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred., • Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations., • Experience with surgical publication submission strategy is strongly preferred., • Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management., • Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required., • Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred., • Excellent problem solving, conflict resolution, and analytical skills is required., • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required., • Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required., • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills., • Able to understand and execute to project details but keep overall “big picture” view of projects, priorities, and strategies is required., • Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred., • Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP), • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred., • Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred., • Legal authorization to work in the United States., • This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies) Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company’s long-term technical vision to create a strong pipeline of customer-focused innovations. Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products. This is a senior technical role overseeing a small team. The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President Technology. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products., • Provide sound scientific leadership, monitoring, and coaching through the initiation, planning and execution their team’s overall activities., • Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials and their use., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Lead material/design/process changes through design control process, with well-documented research/analyses., • Review and author protocols and reports including development studies and design verification/validation activities., • Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives., • Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements., • Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage., • Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments., • Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Act as research liaison between R&D and Quality Control to define product specifications., • Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents, • Provide guidance and support to commercial teams, support introduction of new technologies with development of presentations, sales tools, formulations and applications data., • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Master’s degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline., • A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture, with at least 5 years in a non-academic setting., • A minimum of 2 years of direct management experience., • Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Direct experience in new product development from concept to regulatory approval through launch., • Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required., • Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required., • Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required., • Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities., • Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall “big picture” view of projects, priorities, and strategies., • Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery., • Strong working knowledge of Microsoft Office., • Legal authorization to work in the United States. Preferred Qualifications • Ph.D. in a relevant discipline is strongly preferred., • Experience developing and commercializing products in a highly regulated environment, • Medical device development experience., • Demonstrated expertise in the use, development, and qualificication of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods., • Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485)., • Strong understanding of cGMP, ICH guidelines, • Six sigma green belt or black belt certification., • Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred., • Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously., • Excellent problem-solving skills and a proactive approach to addressing formulation challenges. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits BENEFITS • Competitive annual base salary range of $130,000 - $180,000, depending upon qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job Description About the job Seeking an experienced Product Manager with a strong background in medical devices (spine) and product management to lead the product life cycle from concept and development to innovation of Class I, Class II and Class III medical devices. T The ideal candidate will have expertise in understanding our customers and develop an intuition around our products to ensure exceptional experience from introduction to delivery of product. Proven leadership skills are essential as the role will also involve working with key stakeholders including cross functional leaders, KOL’s, clients and vendors both domestically and international to ensure the successful execution of product to our end user. Key Responsibilities: Product Strategy & Support • Identify and execute product strategy for the company’s full portfolio to ensure it aligns with business goals., • Contribute to the strategic direction while focusing on cutting-edge technologies and providing regular updates to key stakeholders and senior management., • Identify, develop and execute strategic marketing and business plans to ensure maximum outcome with the goal of continued optimization., • Analyze trends and conduct market research and competitive analysis including voice of customer programs from concept to product launch including feasibility assessment, clinical validation and commercialization., • Collaborate closely with surgeons, clinical specialists, and hospital procurement teams to collect feedback and identify new product opportunities and continuous improvement., • Build key metrics and KPIs to optimize marketing and business strategies., • Lead in developing business cases and financial models to support new product programs and existing product enhancements., • Develop and execute comprehensive product and marketing strategies for the orthopedic/spinal portfolio., • Partner with R&D and manufacturing to define product specifications, prioritize features, and ensure timely and compliant product development., • Lead go-to-market strategy, including product positioning, pricing, catalog development, and promotional planning., • Partner with key leaders to ensure successful results with P&L including achieving targets around sales revenue, margin and operating income., • Manage budget forecasts for both business and financial decisions., • Monitor product performance and collect feedback from customers to identify areas of opportunity for continuous improvement., • Maintain various performance dashboards including KPI’s., • Conduct regular analysis to identify areas for improvement including product enhancements., • Education: Bachelor’s degree in Business Administration, Marketing, Engineering, Life Sciences or similar field. MBA or similar advance degree preferred., • 7+ years of experience mid to senior level marketing and/or product management – medical device (spine) industry required., • Experience in the product management of Class I, Class II and Class III medical devices (orthopedic industry a plus) with ability to be solution and results oriented., • Proven ability to influence without direct authority including experience in guiding key stakeholders, senior leadership and cross functional team members toward aligned goals., • Established success rate in testing and launching business processes and initiatives including validating workflow, successful implementations and measurable outcomes., • Strong analytical mindset with ability to interpret market data and customer feedback., • Excellent skills in presentation, communication, leadership, and problem-solving skills., • Computer Programs: MS Office Suite (Excel, Outlook, Word, PowerPoint), ERP Systems a plus., • Endoscopic Technologies: Experience with endoscopic instrument design, optics, and surgical tool integration, • Knowledge of regulatory requirements and clinical practice in medical device industry a plus. This position is full time, on-site and located in our headquarters in Baldwin, NY. An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits. We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email . Powered by JazzHR tblFdPUQkA

Job DescriptionBuyer III – Supply Chain ???? Ramsey, NJ (Onsite) At MMT, our objective is to develop excellence in automation, machine design, material handling, and custom tooling. Each role contributes to the success of the organization through accountability, responsiveness, and a solutions-oriented mindset. We’re looking for an experienced Buyer III to join our Guidewires & Abrasives Division in Ramsey, NJ. This division supports a wide range of industries—from medical device manufacturing to aerospace and precision industrial applications—giving you the opportunity to work across a diverse and technically advanced supply chain. This position reports directly to the Manager, Supply Chain and plays a key role in ensuring materials and services are sourced efficiently, cost-effectively, and in alignment with production and customer needs. What You’ll Do • Manage end-to-end purchasing activities for assigned commodities and suppliers, • Analyze demand, forecasts, and production schedules to ensure material availability, • Negotiate pricing, terms, and delivery schedules with suppliers, • Build and maintain strong supplier relationships while driving performance and accountability, • Identify cost savings opportunities and support continuous improvement initiatives, • Partner cross-functionally with Engineering, Production, and Quality teams, • Monitor supplier performance and resolve delivery or quality issues, • Maintain accurate purchasing data in ERP systemsWhat We’re Looking For, • 5+ years of purchasing or supply chain experience, preferably in a manufacturing environment, • Strong negotiation skills and commercial acumen, • Ability to quickly learn new systems, processes, and product lines, • Experience working with ERP/MRP systems, • Strong analytical and problem-solving skills, • Excellent communication skills and ability to work across teams, • Primarily office-based within a manufacturing environment, • Regular use of computers, ERP systems, and standard office equipment, • May require time on the production floor to support operations and supplier-related activities, • Ability to sit for extended periods with occasional standing and walking, • May occasionally lift or move items up to 15 pounds

Job DescriptionAbout Voyant: Voyant Photonics, based in the heart of New York City, is transforming machine perception with a new class of LiDAR devices that are compact enough to fit in the palm of your hand and powerful enough to measure range, velocity, and reflectivity with unparalleled accuracy. By leveraging cutting-edge silicon photonic chips smaller than your fingertip, we deliver sensors that are not only revolutionary in performance but also affordable enough to integrate into any system. Our technology disrupts the status quo of bulky, expensive, and power-hungry LiDAR systems, making high-precision sensing accessible for widespread adoption in robotics, autonomous vehicles, drones, industrial automation, and beyond. With Voyant, the next generation of machines can see, understand, and navigate the world like never before. Discover how we’re redefining what’s possible by making real products out of cutting-edge research in silicon photonics. Position Overview: We are seeking a highly motivated and self-driven Photonics Test Engineer to take ownership of test development and operations for our cutting-edge silicon photonics FMCW LiDAR technology. This is a hands-on role where you will develop and execute advanced test methodologies, ensure rigorous validation of our photonics devices, and work closely with a multidisciplinary engineering team. You will set a high standard for test execution, troubleshooting, and process improvements, leading by example through direct contributions and technical expertise. Key Responsibilities: * Develop and execute design verification tests, analyze results, and provide feedback to improve device performance. * Define and implement both die-level and wafer-level test solutions in collaboration with design, product, and packaging teams. * Develop production test solutions for silicon photonics components to ensure manufacturability and scalability. * Optimize and standardize test and analysis methodologies to improve repeatability and accuracy. * Bring up, manage, and operate automated wafer-level test (WLT) probers for silicon photonics devices. * Perform routine setup calibrations and ensure quality control in test processes. * Identify and mitigate test challenges, ensuring the execution of large-scale technical projects in a timely and efficient manner. Qualifications: * Education: Bachelor's, Master’s, or PhD in Electrical Engineering, Photonics, Optics, Physics, or a related field. * Experience: Minimum 2 years of hands-on lab experience testing silicon photonics devices or related photonics/optics components. * Technical Expertise: * Strong understanding of optical integrated circuit (PIC) design, testing, and its impact on product yield and performance. * Hands-on experience with optical test and measurement equipment (e.g., optical spectrum analyzers, power meters, interferometers, high-speed photodetectors) and optomechanical alignment tools. * Proficiency in Python for test automation, data analysis, and instrument control. * Knowledge of automated wafer-level testing (WLT) and test methodologies for silicon photonics. Practical experience in WLT is highly preferred. * Experience with fiber alignment automation or active alignment techniques. * Problem-Solving: Strong analytical and troubleshooting skills, with the ability to resolve complex system issues and propose corrective actions. * Communication & Collaboration: * Strong verbal and written communication skills to effectively convey complex test results, analysis, and technical insights. * Ability to work cross-functionally with design, manufacturing, and packaging teams. * Work Ethic & Adaptability: * Highly self-motivated and capable of managing multiple tasks with attention to detail. * Comfortable working in a fast-paced environment with evolving technical challenges. Benefits Package: * Competitive base salary and meaningful equity package. * Comprehensive health benefits (Medical, Dental, Vision). * Unlimited PTO and paid company holidays. * Team events and company meetups. * Complimentary lunch provided daily at our NYC office Equal Opportunity Employer Voyant Photonics is an equal opportunity employer committed to building a diverse and inclusive workplace. We welcome applicants from all backgrounds and do not discriminate based on race, color, religion, gender, gender identity or expression, sexual orientation, pregnancy, marital or partnership status, age, national origin, citizenship, veteran or military status, disability, medical condition, genetic information, caregiver status, or any other characteristic protected by law.

Job DescriptionAbout the Company LTS Lohmann Therapy Systems is a global leader in transdermal and oral thin‑film drug delivery technologies. Our teams have pioneered breakthroughs such as the first contraceptive patch, nicotine patch, oral active ingredient film, and Parkinson’s patch. When you join LTS, you become part of a team that continues to shape the future of patient care and bring life‑changing therapies to market. At LTS, our purpose drives everything we do: We CARE. We CREATE. We DELIVER. We’re committed to fostering an employee experience that reflects our innovation — supportive, collaborative, and empowering. Across our New Jersey and Minnesota locations, you’ll work alongside knowledgeable experts on diverse projects in an environment where every day is different and your contributions truly matter. Job Summary As a Manufacturing and Process Engineer, you will lead equipment reliability efforts for the Fabrication department at the West Caldwell, NJ facility. This includes improving preventive maintenance strategies, implementing Total Productive Maintenance (TPM) systems, and driving Overall Equipment Effectiveness (OEE) measurement. You will partner closely with production leadership to integrate TPM, OEE, and reliability methodologies into daily management—advancing operational excellence and continuous improvement. This is a full time, onsite role located in West Caldwell, NJ • Schedule: Monday–Friday, 8:00 AM–4:30 PM Key Responsibilities • Lead equipment reliability improvement initiatives and long‑term strategic projects., • Enhance and optimize preventive maintenance programs and procedures., • Implement TPM methodologies across the Fabrication department., • Establish and monitor OEE metrics and performance KPIs., • Troubleshoot and support equipment repair activities as needed., • Create, revise, and maintain equipment‑related procedures and documentation., • Partner with cross‑functional teams on change control and continuous improvement efforts., • Lead Lean initiatives and reliability‑focused problem‑solving activities., • Conduct investigations of equipment failures and develop corrective and preventive actions., • Actively participate in departmental and cross‑functional meetings. Minimum Qualifications • Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or related field., • 2–3 years of experience in pharmaceutical, medical device, or industrial manufacturing., • Strong communication skills and solid mathematical/analytical ability., • Ability to wear required PPE: safety glasses, hearing protection, respirator, latex gloves, and Tyvek suit. Preferred Qualifications • Experience with TPM, OEE, and equipment reliability programs., • Prior hands‑on exposure in a regulated manufacturing environment. If this sounds like you, we want to hear from you! LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Description Position Summary We are seeking an experienced Quality Assurance Coordinator to develop, implement, and maintain our quality management systems while ensuring compliance with ASME, ISO 9001, and ISO 13485 standards. This role combines both quality system leadership and hands-on inspection responsibilities within a metal fabrication environment. Key Responsibilities • Develop, implement, and maintain an ISO 9001-compliant Quality Management System (QMS), • Support the company’s efforts to achieve ISO 9001 certification, • Ensure compliance with ASME Section VIII, Division 1 and applicable ISO standards, • Perform quality control inspections in accordance with documented procedures, • Conduct internal audits and ensure ongoing compliance with quality standards, • Lead corrective and preventive action (CAPA) processes, including tracking and follow-up, • Train employees on quality procedures, standards, and best practices, • Manage and coordinate customer audits and notified body inspections, • Monitor, track, and report key performance indicators (KPIs) related to quality, • Collaborate with production and engineering teams to drive continuous improvement initiatives, • Maintain accurate and complete quality documentation and records Qualifications • Minimum 5 years of experience developing and maintaining an ISO 9001-compliant quality system, • Experience in a metal fabrication environment is required, • Strong knowledge of ASME Code (Section VIII, Div. 1) is highly preferred, • Experience with ISO 13485 and medical device manufacturing/sterilization processes is a plus, • Proven experience conducting audits, inspections, and CAPA processes, • Strong attention to detail, organization, and problem-solving skills, • Excellent communication and training abilities Additional Requirements • Ability to work both independently and collaboratively across departments, • Willingness to travel domestically and internationally as needed

Job DescriptionThis is a temporary 6-month contracted W2 position. The pay range for this position is $40-$45/hr (depending on experience) • Interprets customer specifications to define requirements for mechanical designs., • Performs first principal analysis related to appropriate aspects of mechanical design., • Applies the 3D CAD system to create mechanical design and drawings., • Develops detailed fabrication and assembly drawings and performs tolerance analysis., • Develop prototypes for design evaluation., • Troubleshoot and resolve design & processing issues., • Contributes to details of design documentation using electronic documentation systems., • Collects, analyzes and interprets data to propose recommendations., • Develops & execute design verification protocols and technical reports., • Work with internal and external resources on fabrication, inspection, and testing of new product parts and assemblies., • Develop & debug prototype tooling / equipment and processes., • Develop test methods and fixtures., • Formulate plans & methods to accomplish assignments with appropriate oversight., • Works independently and prioritizes assigned tasks with guidance., • Contribute to project planning activities., • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Competent in use of Microsoft Office tools., • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes., • Familiarity and the ability to operate basic shop equipment such as hand tools, a drill, and Dremel., • Understand & interpret simple wiring diagrams., • BS in engineering discipline, mechanical preferred., • Minimum 2-4 years related experience, or an MS and less than one year experience., • Experience with a solid modeling CAD program, preferably Solidworks., • Experience in medical equipment / device design with experience in electromechanical, electro-pneumatic, and/or blood pumping equipment development., • Knowledge in medical device industry regulations and practices – ISO 13485, ISO 7198 & GMP., • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat., • Experience with Microsoft Visio and Microsoft Project preferred.#LI-RS1 Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . Powered by JazzHR sQgsnMwpe0

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Production Technician I is responsible for the aseptic manufacturing of Cresilon’s products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). • Perform line clearance of assigned production areas as required., • Perform equipment set up and disassembly activities., • Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment., • Formulate, fill, and pouch product in accordance with SOPs., • Troubleshoot all operating deviations and issues and coordinate with other functions when required., • Report both machine and operating deviations to area supervisor or designee., • Perform routine, preventative maintenance on equipment., • Perform cleaning and disinfection of the manufacturing spaces., • Perform cleaning and sterilization of manufacturing equipment., • Perform visual inspection of components and/or product in accordance with SOP’s and cGMP’s., • Perform sampling, intermediate, and finished goods packaging as per SOPs., • Package and ship raw materials for sterilization., • Perform material receiving, staging, material movements, and material replenishment as per SOPs., • Transport samples, materials, and equipment between multiple facilities., • Complete data entry and generate reports for material inventory movements., • Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards., • Maintain a clean production environment during shift., • Report all actual, near misses and potential accidents for further investigation., • Take immediate action to resolve any near miss situations., • Assist in investigation of all actual, near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently., • Assist in project commissioning and validation activities, as necessary., • Prepare samples or prototypes as required for testing, or other evaluations, • Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process., • Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor Led (TM3/TM4), and On-the-Job Trainings (TM5)., • Oversee training of junior employees on production processes as assigned., • Ensure proper communication and handling over of shift duties., • Support Environmental and Personnel Monitoring (EM/PM) activities as directed., • HS Diploma or Equivalent with 2+ years of relevant manufacturing experience in the pharmaceutical, biotechnology, or medical device industry OR 2 or 4 year degree with 0+ years of relevant experience., • Ability to read, understand, and execute written work instructions., • Ability to complete documentation accurately., • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals, • Ability to become gowning qualified to work in a cleanroom environment., • Ability to problem solve and achieve business objectives., • Ability to adapt training approach., • Willingness to be flexible, and open minded to new processes or changes in direction., • Team oriented, building relationships with peers and managers in a proactive manner., • Excellent verbal and written communication skills., • Proficient in Microsoft Office (Word, Excel, Outlook)., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Monthly MetroCard Reimbursement This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionValidation Specialist Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines in New Jersey. The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc., • Execute IQ/OQ and /or PQ protocols, • Prepare final reports for executed protocols, • Prepare final reports for vendor IQ, OQ and/or PQ protocols, • Review of executed IQ/OQ/PQ protocols and raw data, • Perform periodic review/requalification of validated equipment, systems and cleanrooms, • Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met, • Assembling validation related documents; and filing/archiving approved documents, • Maintaining electronic records.REQUIREMENTS, • BS/BA in engineering or a related Science discipline, • 3-7 + years of validation experience, • Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc., • Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11., • Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary., • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management., • Must be a dedicated self-starter with a high energy level and able to achieve results., • Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution., • Good time management skills to manage and meet deadlines., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment., • Good computer skills and Microsoft Office knowledge., • Ability to multi-task team is essential., • Flexible and able to adapt to company growth and evolving responsibilities., • Highly organized, detail oriented, and ability to manage multiple priorities., • Ability to perform the job under direct or indirect supervision, • Must have the ability to work in a team-oriented environment and with clients, • Must have the ability to work with specialized equipmentMay occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Ability to work in cleanroom environment for a moderate amount of time.Ability to lift, transfer, or ship validation equipment or related accessories.While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. Must where PPE when appropriate. This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

Job Description Electrical Estimator Electrical Contracting – Electrical Construction (Commercial & Industrial) We are seeking a motivated Electrical Estimator with 1–5 years of experience to join a growing commercial/industrial electrical contracting team. This role is ideal for someone looking to build a long-term career in estimating and preconstruction, working on projects typically ranging in the $100K to $3 Million dollar area. You will support senior estimators and project teams in preparing accurate, competitive bids while gaining exposure to a wide range of electrical construction projects. This is a strong opportunity for someone earlier in their career to learn from senior team members, gain exposure to larger projects, and grow into a high-impact role within a reputable electrical contractor. Key Responsibilities • Assist in preparing accurate cost estimates and bid proposals for commercial and industrial electrical projects, • Perform quantity takeoffs from drawings, specifications, and bid documents, • Analyze blueprints, electrical plans, and project specifications, • Solicit and review vendor and subcontractor quotes, • Support the development of labor, material, and equipment cost estimates, • Use estimating software (e.g., Accubid, ConEst, McCormick) to build estimates, • Collaborate with project managers, engineers, and field teams, • Participate in pre-bid meetings and site walks as needed, • Help maintain and update cost databases and historical pricing, • 1–5 years of experience in electrical estimating or electrical construction (field experience is a plus), • Knowledge of commercial and/or industrial electrical systems, • Ability to read and interpret electrical drawings, specifications, and one-line diagrams, • Familiarity with estimating software such as Accubid, ConEst, or McCormick, • Proficiency in Microsoft Excel and Office Suite, • Strong attention to detail and organizational skills, • Effective communication and teamwork abilities, • Understanding of NEC codes and construction practices, • Experience working for an electrical contractor / electrical construction firm, • Exposure to projects such as:, • Office buildings, • Warehouses / distribution centers, • Manufacturing facilities, • Competitive base salary, • Comprehensive benefits package (medical, dental, vision), • 401(k) with company match, • Paid time off and holidays, • Clear career growth path into Senior Estimator or Project Management, • Stable backlog of commercial and industrial work #Construction #Associate #LI-AS1 Key Words: MEP, Electrical Construction, Electrical Contractor, Electrical Project Manager, Project Manager, Estimator, AccuBid, ConEst, McCormick, EBM, Electrical Bid Manager, Electrical Contracting, OST, On-Screen Takeoff. Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job DescriptionLitigation Paralegal Scarsdale, NY · On-site · Full-time $60K–$80K/yr · Easy Apply We’re seeking a motivated Litigation Paralegal to join a busy, collaborative law team in Scarsdale, NY, an attractive and convenient location with a vibrant community and excellent amenities. About the Role As a Litigation Paralegal, you will support multiple senior attorneys by preparing, filing, and coordinating legal documents, managing busy calendars, maintaining case files, and assisting with depositions and court proceedings. This role combines hands-on legal work with administrative responsibilities in a fast-paced but collegial environment. Key Responsibilities: * Serve as primary paralegal for multiple senior litigation attorneys and handle all paralegal work on their cases. * Finalize, format, file, and serve legal documents; prepare tables of contents and authorities. * E-file in federal and state courts, prepare courtesy copies, and assist with ADR proceedings. * Arrange depositions and assist with preparation, including exhibits and binders. * Maintain attorney calendars, deadlines, and case files—both physical and electronic. * Prepare simple legal documents using firm templates (subpoenas, discovery demands, court forms). * Assist with document productions, Bates stamping, and conflict checks. * Answer firm phones and manage incoming mail as needed. Requirements: * 1–2 years of paralegal or legal assistant experience. * Advanced MS Word skills. * Experience e-filing in NY/NJ state and federal courts; PA courts a plus. * Familiarity with law firm CRM/document management/time entry systems (NetDocs and Finance Core a plus). * Proficiency with Westlaw research and cite-checking. * Superior organizational skills, attention to detail, and ability to multitask. * Positive, team-oriented attitude and willingness to work overtime as needed. Why You’ll Love Working Here: * Fast-paced but supportive and collegial environment. * Opportunity to grow professionally with senior attorneys. * Convenient location that is beautiful, walkable, with excellent schools, dining, and commuting options. An Equal Opportunity Employer committed to diversity in the workplace. We celebrate the unique contributions that each team member brings to our organization. Please reach out for additional info. I have over 100+ roles open daily! Please add me on Linked in. ---No Third Parties--- Michael Sardella| Liberty Personnel Services, Inc. 1001 Conshohocken State Rd, Ste 2-410| West Conshohocken, PA 19428 #newyork #junior #litigation #paralegal Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job DescriptionQuality Management Systems Supervisor Job Summary The Quality Management Systems Supervisor will oversee the development, implementation, and maintenance of the organization’s Quality Management System (QMS) to ensure compliance with industry regulations and standards (ISO 9001, ISO 13485, AS9100). Reporting to the Director of Quality Affairs, this individual will drive continuous improvement, support in leading in internal/external audits, manage CAPA processes, and provide cross-functional training to enhance quality awareness. Key Responsibilities • Manage the QMS structure, ensuring all policies, procedures, and Work Instructions (SOPs) are compliant with regulatory requirements and align with company strategic goals., • With guidance from the Quality Affairs Director, lead both internal and external audits (customer, registrar, regulatory), coordinate audit finding responses, and verify the effectiveness of corrective actions., • Lead root cause analysis (RCA) for non-conformances, customer complaints, and deviations, implementing effective Corrective and Preventive Actions (CAPA)., • Drive continuous improvement initiatives using lean methodologies, SPC (Statistical Process Control), and data analysis to enhance operational efficiency., • Manage the electronic Quality Management Systems (eQMS) and ensure Document Control processes are current, accurate, and compliant., • Confirms alignment of all Quality programs within the organization., • Monitor and ensure the organization’s commitment to quality meets or exceeds customer requirements and the relevant regulatory standards., • Develop, trend, and report key QMS performance metrics (KPIs) to senior management and provide solutions to guide data-driven decision-making., • Develop training materials and educate staff on QMS procedures, GMP (Good Manufacturing Practices), or regulatory compliance to cultivate a culture of quality., • Minimum of 5 years of experience in a leading role in Quality Management Systems or Quality Assurance in the medical device industry required (spine or neuro device companies a plus)., • Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field. Master’s degree will be considered for 1 year work experience in related QMS field in medical device industry (preferably spine or neuro)., • Strong knowledge of ISO 9001, ISO 13485, or AS9100:2016 standards., • Leadership ability in root cause analysis tools, Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), and electronic QMS software., • Certified Internal Auditor (ISO 9001/13485) preferred., • Lean Six Sigma Certifications preferred (Black Belt and/or Green Belt)Required Skills & Competencies, • Excellent written and verbal communication skills for interfacing customers and regulators., • Proven ability to partner and influence cross-functional teams, lead/mentor through collaboration and influence without direct authority., • Strong analytical abilities to interpret data and implement effective, sustainable solutions., • Proficient in problem solving with independent thought and judgement while using resources both internally and externally., • Work efficiently and proactively cross functionally in a team setting while being sensitive to deadlines., • High level of accuracy in document review and compliance assessment., • Successful record of ability to work both independently and in a team environment., • Skilled in statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis for data-driven decision-making., • Determined and proactive mindset who is motivated to make a difference with a high standard of excellence.Preferred Qualifications, • ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)., • Experience in a heavily regulated industry (Medical Device or Pharma). An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits. We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email . Powered by JazzHR xLI3YJSudb

Job Description ASSISTANT PROJECT MANAGER - HIGH END RESIDENTIAL Exciting opportunity to join one of New York City's leading high-end residential builders. • Assist in planning, coordinating, and executing high-end, custom residential construction projects from start to finish., • Collaborate with project managers and other stakeholders to ensure project goals are met., • Monitor project schedules, budgets, and resources to maintain efficiency., • Oversee subcontractors and ensure compliance with safety and quality standards., • Prepare and maintain project documentation, including reports and schedules., • Address any issues or challenges that arise during project execution., • Provide regular updates and progress reports to project stakeholders. Send resume to: Mark W. Wonders | Senior Executive Recruiter | Liberty Personnel Services, Inc. #LI-MW1 #ResidentialConstruction #JuniorLevel Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description The Continuous Improvement Manager is responsible for leading, developing, and executing strategies to drive operational excellence across the medical device manufacturing organization. This role champions Lean, Six Sigma, and problem‑solving methodologies to improve product quality, reduce waste, enhance cost efficiency, and ensure regulatory compliance. The Continuous Improvement Manager partners closely with Manufacturing, Quality, Engineering, Supply Chain, and Regulatory Affairs to standardize processes and cultivate a culture of continuous improvement. Key Responsibilities Continuous Improvement Leadership • Develop and implement sitewide continuous improvement strategies aligned with business goals., • Facilitate Kaizen events, value stream mapping, root cause analysis (RCA), and other improvement workshops., • Mentor and train employees at all levels in CI tools, Lean thinking, and structured problem-solving., • Analyze production and quality performance to identify opportunities for efficiency, cost reduction, and throughput improvements., • Drive initiatives using DMAIC, PDCA, 5S, standard work, and other Lean/Six Sigma methodologies., • Ensure improvement projects support and strengthen compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements., • Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation., • Plan, execute, and sustain medium‑to‑large scale CI projects, ensuring milestones are met., • Develop business cases, project charters, and ROI analyses to justify improvement initiatives., • Promote a culture of operational excellence and accountability throughout the organization., • Create and maintain training materials, SOPs, and standardized processes., • Bachelor’s degree in Engineering, Manufacturing, Operations, or related field., • 5+ years of experience in continuous improvement, operational excellence, or process engineering within a regulated manufacturing environment (medical device preferred)., • Strong working knowledge of Lean, Six Sigma, and structured problem-solving tools., • Experience working within FDA-regulated or ISO 13485 environments., • Demonstrated success leading CI projects and cross-functional teams., • Excellent analytical, communication, facilitation, and change‑management skills., • Familiarity with statistical software (Minitab, JMP, etc.)., • Experience with automation, digital manufacturing tools, or Industry 4.0 technologies.

Job Description Electrical & Controls Engineer II ???? Ramsey, NJ (Onsite) ???? Salary Range: $92,603 - $143,535 Build the machines behind precision manufacturing. At Medical Manufacturing Technologies (MMT), we design and manufacture highly specialized automation equipment used by leading manufacturers around the world. Our Guidewires & Abrasives division in Ramsey, NJ develops advanced precision machinery used to produce components for industries including medical device, aerospace, automotive, and other high-performance manufacturing sectors. We’re looking for an Electrical & Controls Engineer II who enjoys solving complex engineering challenges and bringing automated systems to life. This role combines electrical engineering and controls engineering, giving you the opportunity to design electrical systems, develop PLC logic, and support advanced automation equipment from concept through commissioning. What You’ll Do Controls Engineering • Develop and modify PLC control logic for automated manufacturing equipment, • Design and configure HMI interfaces for machine operation and diagnostics, • Integrate and tune servo motion control systems, • Design electrical systems, including schematics, panel layouts, and wiring diagrams, • Select automation components including PLCs, drives, motors, sensors, and safety systems, • Maintain electrical documentation including schematics, BOMs, and I/O lists, • Bachelor’s degree in Electrical Engineering, Controls Engineering, Automation Engineering, or related field, • 3–6 years of experience in electrical, controls, or automation engineering, • Experience with PLC programming and industrial automation systems, • Experience designing electrical systems for automated equipment At MMT, engineers work on custom automation systems used by global manufacturers across multiple industries. Our Ramsey engineering team develops precision machinery that supports both medical device production and high-performance manufacturing applications beyond healthcare. You’ll work alongside experienced engineers and see your designs move from concept to fully functioning machine systems. If you're passionate about automation, machine design, and solving complex engineering challenges, we’d love to hear from you. Apply today to join the MMT engineering team.

Job DescriptionThis is a temporary 6-month contracted W2 position. The pay range for this position is $70-$85/hr (depending on prior experience) Job Functions: • Applies expertise as an emerging authority in the mechanical engineering discipline., • Conceives and develops solutions to difficult analytical and pneumatic/mechanical/electrical design problems., • Participates in establishing system or component design objectives and writes portions of complex specifications and engineering reports., • Reviews and helps to develop product specifications, • Conducts conceptual design studies using MCAD and other applicable design tools. Collaborates with other engineering functions, • Develops prototype hardware using internal manufacturing resources and outside vendors, • Tests product to verify that designs meet specification requirements such as environmental, regulatory and safety requirements, • Generates documentation supporting the design, • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Familiarity with dimensioning and tolerance, thermal and structural analysis, and vibration testing/analysis, • Intermediate knowledge of FDA, IEC and UL standards relating to medical electronic equipment, • Strong technical and analytical ability, verbal and written communication skills, ingenuity and creativity, interpersonal and project management skills, • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes, • BSME or MSME and a minimum of 10 years of related experience in design/product development of electro pneumatic assemblies including technical supervision of sub-projects, • Formal training in basic and advanced topics in Solid Works is strongly preferred, • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat, • Advanced proficiency with SolidWorks, MCAD/CAE software and database management software preferred, • Advanced proficiency with Microsoft Visio and Microsoft Project preferred Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . Powered by JazzHR QpHnpP1sVI

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description Job Title: Assembly Operator Job Description As an Assembly Operator, you will be responsible for completing job cards, routers, and job documentation as required. You will operate equipment such as lathes, welders, presses, grinders, cable cutters, swagers, and packaging equipment necessary for manufacturing cable assemblies. Additionally, you will maintain material traceability by completing records of materials usage for each job, perform visual and tactile inspection of assembled parts, and gather samples for testing and inspection. Responsibilities • Complete job cards, routers, and job documentation., • Maintain material traceability by completing records of materials usage., • Monitor and perform visual and tactile inspection of assembled parts., • Perform proof-loading of assembled parts., • Gather samples for start-up and in-process testing and inspection., • Package and label processed material according to job card instructions., • Proficiency in assembly line and visual inspection., • Experience with hand tools and cable assembly., • Ability to perform visual inspection of completed products., • Ability to self-motivate and problem-solve in a fast-paced setting., • Excellent attention to detail., • Good documentation practice., • Understanding of part workmanship., • Ability to analyze data and make recommendations., • Ability to troubleshoot manufacturing defects., • Prior manufacturing experience is preferred. This is an entry-level manufacturing position that offers the opportunity to learn Good Manufacturing Practices (GMP) and gain exposure to medical device manufacturing. There are growth opportunities and a long-term career path available on a growing team. Work Environment There are six openings with four positions on the first shift, Monday to Friday from 8 AM to 5:30 PM, and two positions on the second shift, Monday to Friday from 5 PM to 1 AM (training on the first shift for two months is required). There is an option for Saturday overtime depending on production needs, from 8 AM to 3 PM. Job Type & Location This is a Contract to Hire position based out of Allendale, NJ. Pay and Benefits The pay range for this position is $17.00 - $18.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Apr 10, 2026. About Aerotek: We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.