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Job Description Maintenance Manager – Buffalo, NY Overview A food production facility in Buffalo, NY is seeking an experienced Maintenance Manager to oversee the maintenance, repair, and reliable operation of all equipment and physical plant systems. This leadership role is responsible for implementing maintenance strategies that reduce downtime, ensure food safety compliance, and maximize production efficiency within a regulated manufacturing environment. Responsibilities • Lead, mentor, and supervise the maintenance team, providing ongoing training and performance development., • Establish maintenance priorities and allocate resources effectively across multiple shifts., • Promote a safety-first culture and ensure compliance with OSHA and all company safety standards., • Develop and manage departmental budgets, including repair, parts, and contractor expenses., • Coordinate maintenance activities with production, quality assurance, and engineering teams., • Implement and manage preventive and predictive maintenance programs to ensure equipment reliability., • Oversee installation, troubleshooting, and repair of mechanical, electrical, pneumatic, and hydraulic systems., • Track and analyze key performance indicators (KPIs), including Overall Equipment Effectiveness (OEE), to drive continuous improvement., • Utilize a Computerized Maintenance Management System (CMMS) to manage work orders, inventory, and equipment history., • Manage vendor and contractor relationships for repairs, services, and new installations., • Ensure maintenance operations comply with GMP, HACCP, and other food safety standards., • Participate in internal and external audits to maintain regulatory compliance., • Manage capital projects involving facility upgrades and equipment installations., • Support Lean Manufacturing and Total Productive Maintenance (TPM) initiatives to enhance efficiency and reduce costs. Qualifications • Bachelor’s degree in mechanical, electrical, or industrial engineering (or equivalent technical experience)., • 5+ years of experience in industrial maintenance, preferably within food manufacturing., • Proven leadership or supervisory experience in a production environment., • Strong technical expertise in PLCs, 480V 3-phase electrical systems, and mechanical troubleshooting., • Working knowledge of food safety and occupational safety regulations (HACCP, GMPs, OSHA, FDA)., • Proficiency with CMMS and Microsoft Office applications., • Excellent leadership, communication, problem-solving, and time-management skills.

Job Description Join a team that nourishes life from farm to table! Upstate Niagara Cooperative, proudly owned by 200+ local family farms, is one of America’s largest and most stable dairy cooperatives. Guided by farmer- and employee-led values, we process and market high-quality milk, yogurt, dips, sour cream, cottage cheese, and more under our trusted brands: Upstate Farms®, Bison®, Milk for Life®, and Intense Milk®. Here, you’ll support sustainable farming, strong communities, and the mission to deliver fresh, local dairy to families every day. Job Summary: The Production Manager will oversee daily operations in a high-volume fluid milk processing plant, ensuring safe, efficient, and compliant production. This role is responsible for leading and developing production teams, driving continuous improvement, and meeting key performance goals in safety, quality, efficiency, and cost. The Production Manager will coordinate closely with Quality, Maintenance, and Supply Chain to optimize workflows, maintain regulatory compliance (SQF, HACCP, FDA, USDA), and deliver consistent product to customers. Strong leadership, problem-solving, and data-driven decision-making skills are essential to success in this role. Qualifications: • 5+ years of supervisory or management experience in food or beverage manufacturing, preferably dairy or fluid milk., • Strong knowledge of dairy processing operations, blending pasteurization, homogenization, and filling/packaging equipment., • Familiarity with SQF, HACCP, FDA, USDA, and other regulatory requirements for fluid milk production., • Demonstrated ability to lead and develop teams in a fast-paced, 24/7 production environment., • Proven track record of driving operational efficiency, reducing waste, and improving plant performance metrics (OEE, yields, downtime)., • Experience with lean manufacturing, continuous improvement, and root cause problem-solving., • Strong safety mindset with the ability to foster a culture of accountability and compliance., • Excellent communication and collaboration skills across departments (Quality, Maintenance, Logistics, and HR)., • Proficiency in production scheduling, inventory control, and ERP/MES systems., • Proficient in Microsoft Office programs (Excel, Word, Outlook, PowerPoint) for reporting, analysis, and communication., • Ability to analyze production data and generate actionable insights for performance improvement., • Flexibility to work varying shifts and respond to plant operational needs as required., • Experience collaborating with the cooler storage team., • Bachelor’s degree in food science or business discipline. The successful candidate will have proven experience managing dairy or food manufacturing operations, with strong knowledge of fluid milk processing, filling, and packaging systems. They should demonstrate success in driving efficiency, improving yields, reducing downtime, and ensuring compliance with SQF, HACCP, FDA, and USDA requirements. Proficiency in ERP/MES systems and Microsoft Office programs is essential, along with a track record of leading teams, fostering a culture of safety, and delivering measurable production improvements. Physical demands: This position requires the ability to work in a manufacturing environment with exposure to varying temperatures, noise, and standing or walking for extended periods. The role may involve climbing stairs, bending, and lifting up to 50 pounds as needed. Flexibility to work off-shifts or weekends to support production operations is also required. Job Duties and Responsibilities: • Oversee daily fluid milk processing, filling, and packaging operations to meet production schedules., • Ensure compliance with SQF, HACCP, FDA, USDA, and all company quality and safety standards., • Lead, coach, and develop production supervisors and frontline employees to build high-performing teams., • Monitor production metrics (OEE, yields, downtime, waste) and implement improvements to achieve efficiency goals., • Collaborate with Quality, Maintenance, and Supply Chain to optimize workflows and resolve production issues., • Drive continuous improvement initiatives using lean manufacturing and root cause problem-solving., • Maintain accurate production records, reports, and documentation in ERP/MES systems., • Manage labor, materials, and resources to control costs while meeting customer demand., • Foster a culture of safety, accountability, and employee engagement., • Support training and cross-training efforts to strengthen workforce flexibility. *The salary range indicated in this posting represents the minimum and maximum of the salary range for this position. Actual salary will vary depending on factors including, but not limited to, budget available, prior experience, knowledge, skill and education as they relate to the position’s qualifications, in addition to internal equity. The posted salary range reflects just one component of our total rewards package. Other components of the total rewards package may include participation in group health and/or dental insurance, retirement plan, wellness program, paid time away from work, and paid holidays. Upstate Niagara Cooperative, Inc. is committed to equal employment opportunity for all, 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.

Job Description Maintenance Technician Lornamead is currently seeking a Maintenance Technician to join our team! Lornamead, Inc. manufactures and supplies, hair care, skin care, oral care, and bath products in America. The company offers toothpastes, teeth whitening products and oral analgesics for drug chains, and national food retailers. The company is headquartered in Tonawanda, New York. Your Challenge: • Performs maintenance & repairs related to building, grounds and building systems, in one or more areas such as electrical, plumbing, painting and grounds-keeping., • Assist in equipment installations, upgrades, and continuous improvement projects., • Establishes, monitors, and carries out preventative maintenance procedures and schedules for building, building systems and grounds. Ensures building and systems meet all safety, security and fire regulations and policies. Makes recommendations for major repairs and purchases to supervisor., • Performs painting, mechanical and plumbing maintenance and repairs such as installing switches, replacing lights and other basic electrical repairs, applying paint and other finishes, repairing drywall and floors, disassembling and reassembling equipment, replacing sinks and toilets and applying finishing material as needed to maintain appearance., • Collects and removes garbage and recyclable materials and ensures the safe disposal of hazardous waste., • Cleans external areas such as entranceways, sidewalks and parking lots using manual and power brooms, rakes, shovels, pressure washer and other equipment to remove dirt, leaves, and other refuse (landscaping and snow removal not included)., • Transports equipment, furniture and supplies manually and/or using aides such as dollies and carts., • Document maintenance activities in accordance with cGMP and FDA standards., • 2-5 years of building systems and maintenance experience in a manufacturing environment, • Ability to thrive in a dynamic environment, • Ability to multitask and work on multiple projects at the same time

Job Description We are seeking a dynamic Technical Writer to join our Engineering Department. The Technical Writer is responsible for creating, revising, and maintaining technical documentation that supports manufacturing processes, equipment operation, quality standards, and regulatory compliance. This role collaborates with engineers, safety officers, maintenance crews, sales managers, and operations managers to produce technical materials that enhance operational efficiency and worker safety. This is an on-site role in our Buffalo, NY headquarters. Responsibilities: • Develop and update manufacturing documentation, including but not limited to work instructions, equipment manuals, maintenance procedures, safety documentation, and Standard Operating Procedures (SOPs), • Translate complex technical information into clear, concise content for diverse audiences (operators, technicians, auditors, etc.)., • Work with engineers and production staff to gather technical input and ensure documentation reflects current practices and specifications., • Ensure all documentation meets internal quality standards and regulatory requirements (e.g., ISO, OSHA, FDA if applicable)., • Organize and maintain controlled document libraries using document management systems (DMS)., • Participate in audits and process improvement initiatives as needed., • Provide support for training materials, visual aids, and technical diagrams. Qualifications: • Degree in Technical Communication, Engineering, or a related field., • 2+ years of experience in technical writing, preferably in a manufacturing or industrial environment., • Mechanical aptitude, • Strong attention to detail and ability to work independently., • Excellent written communication skills and grammar., • Proficiency in Microsoft Office and experience with document control systems., • Ability to interpret engineering drawings, process maps, and schematics., • Experience with CAD software or visual documentation tools preferred., • Knowledge of regulatory and compliance documentation standards., • A passion for technical writing., • An elevated level of accountability, setting a standard for ownership and integrity., • Willingness to collaborate with manufacturing personnel, engineering designers and technical service field representatives in a hands on role.

Job Description Job Title: Senior Product Manager, Job Title: Senior Product Manager, Global Product Management Reports To: VP, Global Product Marketing, ZeptoMetrix Position Location: Buffalo, NY Franklin, MA highly preferred FLSA Status (Exempt/Non-Exempt): Exempt FLSA Status (Exempt/Non-Exempt Position Summary: The Senior Manager, Global Product Management for Molecular Diagnostics is accountable for creating and delivering the new product pipeline for infectious disease and genetic testing. The role is responsible for managing the assigned product portfolio, delivering growth, profitability and share gain for the assigned portfolio, effectively ensuring a strong and competitive portfolio of products that outperforms competition and exceeds customer expectations. This role will leverage market and customer insights into enhancing and developing new and innovative products within the portfolio, as well as partnering with internal teams to ensure final product exceeds customer expectations. The Senior Product Manager will be responsible for driving growth by developing and implementing strategies to further expand the Clinical Lab market for both existing and new products. Key Responsibilities: • P&L responsibility for maximizing global revenues, margins, and growth of assigned products by creating strong and innovative strategic plans for growth within the market., • Drive revenue growth through overall product life cycle management including, but not limited to product line strategy and vision, product line road mapping, product line development in collaboration with Research & Development, Operations, Regulatory Affairs and Commercial teams. Implement appropriate programs to either internally develop, contract manufacture, license or source the appropriate products with the goal of driving revenue & profitability growth of the category portfolio., • Drive product area efforts and coordinate with Corporate Development (M&A) and R&D/engineering to ensure the product roadmap achieves market-positioning, timeline and revenue targets as planned. Look for opportunities to anticipate and respond to market and customer needs by optimizing product portfolio across all possible markets, both existing and new., • Develop strategies with Sales and Marketing to drive market share growth., • Develop and implement appropriate and effective global pricing strategies with Pricing team to maximize profitability and margin., • Partner with Supply Chain to support supplier consolidation and cost reduction initiatives., • Execute competitive assessments and voice of customer/market research to gain market insights for competitive, differentiated product strategies. Demonstrate strong global market understanding and stay current on market direction and drivers through a variety of means including, but not limited to, direct interactions with customers, outside suppliers, partners, and industry contacts., • Gather and prepare all necessary product and technical information and content for the introduction of new products and ongoing product documentation, applications, and testimonials for all products to enable an exceptional customer experience, drive brand awareness and ensure customer loyalty., • Partner closely with the commercial and customer service teams to develop and drive sales enablement strategies, programs and resources to support both the internal MolDx sales team and global distribution channels., • Scientific marketing for the assigned portfolio and markets, including the creation of a Global Speakers Bureau and the development and execution of a Global Publication Plan to produce scientific posters, papers, webinars, and articles in collaboration with commercial and science teams., • Collaborate with global demand generation and customer experience teams to develop and execute strategies aimed at achieving revenue targets for the U.S. clinical lab market., • Performs other duties as assigned Education: • Must possess a Bachelor’s Degree - B.A / B.S. with major/minor in sciences/business required – business, marketing, science, chemistry or engineering; MBA / Master’s Degree / Graduate degree a plus Experience: • Must have at least 10 years of progressive experience in product management / product development, marketing or program/project management within R&D (technical) or Marketing (business/administrative) domains; familiarity with products used in regulated environments, cold storage, or cold chain environments preferred., • Knowledge of molecular diagnostics, infectious disease and genetic testing, laboratory products/applications, actual working laboratory or process / industrial experience or understanding of customer requirements in laboratory or process / industrial products considered / strongly preferred Minimum Requirements/Qualifications: • Potential candidates should have relevant experience in the following areas:, • Proven track record of commercial/program success within a product area, • Prior commercial experience in a product management, sales, or marketing function, • A technical background in life sciences (biology, biochemistry, chemistry) that includes an awareness of technology trends and the evolution diagnostics, especially molecular diagnostics, applications, • Industry-related experience in healthcare or laboratory-based life science markets preferably in diagnostics & molecular control markets., • Understanding of FDA and international regulated markets and how such regulations impact product design, labeling, manufacture, and testing., • A high level of initiative, creativity, and work with little supervision. Ability to build strong executive and peer relationships., • Ability to travel up to 25%, including some international., • Willing to take calculated risks and to learn from mistakes., • Demonstrated ability to successfully balance the achievement of short-term objectives with longer-term strategic goals., • Must possess strong negotiation skills to independently negotiate and manage a relationship with external suppliers/management level personnel, representing company’s interests., • Proficient in standard computer applications, with excellent skills in Excel, Word and PowerPoint. Must be able to obtain, manipulate and analyze data and effectively collate and present information into reports or presentations., • Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints, • Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization, • Salary Range: $125k-$135k, depending on location, experience, and qualifications. Plus bonus., • Benefits coverage begins day 1, including the following:, • Medical, Dental, Vision Insurance, • Disability Insurance, • Life Insurance, • 401(k) company match, • Paid Time Off (15 days annually), • Paid Holiday time (10 company-designated days), • Tuition Assistance, • Additional benefits available with company package This position has not been approved for Relocation Assistance. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Job DescriptionSalary: $20/hr DOE Position Summary: Performs various microbiological sampling and testing in an FDA regulated environment, including personnel and environmental monitoring. Essential Functions: • Perform and review environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable surface, personnel, and non-viable particulate) as well as inspection for compliance., • Perform and support Media Fill Validations, Engineering Validations and Cleaning Validations., • Accurate/legible completion of records and documents for tests performed, and accurate computer data entry/trending/presentation., • Raw Material/Prefiltration Bioburden/Water sample/Filter integrity testing., • Media check in and growth promotion., • Equipment preparation and autoclaving., • Preparation of microbial ID samples., • Off testing of incubated environmental monitoring media, testing samples, and Media Fills., • Use standard laboratory equipment including but not limited to balance, incubator, autoclave, pipettes, and water bath., • In-process/finished product sample inspection and submission to in-house/third party laboratories., • Stocking/ordering lab supplies., • Assist with revision of microbiology/laboratory procedures and documentation., • Maintenance of close communication and interaction with QC/QA/Production management., • Utilization of programs for daily workflow (e.g. LIMs)., • Utilization of a Quality Management System (QMS) for training and document review/ improvements., • Potential involvement in procedural/policy improvements within the department., • Support microbiology laboratory investigations including NONC/EE/Issue reviews/OOS/OOT/No Tests/CAPA., • Responsible for promoting and maintaining safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner., • Responsible for cleaning and upkeep of the laboratory and testing areas., • Support gown assessments as needed., • May perform other duties as qualified/assigned, including but not limited to Sterility , Endotoxin , MET testing, NONC issuance., • Any additional activities as dictated by updates to Standard Operating Procedure and Policies to ensure compliance with cGMP and regulatory bodies. Education and Experience: • A bachelors degree (science related field preferred) or associates degree is preferred., • In lieu of a degree, a high school diploma or equivalent and a minimum of 2 year experience in a regulated environment or Pharmaceuticals may be considered. Knowledge, Skills and Abilities: • Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown upon completion., • Accurate/legible completion of records and documents for tests performed, and accurate computer data entry., • Good time management skills, attention to detail, ability to adhere to implemented standard operating procedures/policies, ability to communicate professionally with contract laboratories regarding sample testing, communication with others, and flexibility for new opportunities/tasks., • Works well independently and in a team orientated environment., • Experience in microbiological principles and applications related to microbial ID, validation, or clean room technology., • Experience with standard laboratory equipment including balance, incubator, autoclave, pipettes, or water bath is preferred., • Knowledge of ISO, USP or GMPs standards is a plus., • Knowledge of computer skills (e.g. Windows, Word, Excel, Power Point) Physical Requirements / Working Conditions: • Must have a reliable method of transportation for work travel., • Ability to wear high level full body aseptic gowning with face mask for long periods of time is required., • Ability to stand for long periods of time.

Job Description We are seeking a Controls/Automation Engineer to design and implement SCADA, PC, and PLC software solutions that drive equipment automation. This role involves configuring industrial networks, preparing control system documentation, and ensuring compliance with FDA and GAMP standards. You will collaborate with suppliers, support project teams, and provide technical guidance across the full project lifecycle, including troubleshooting and assisting field engineers and end users. Pay rate: $70K-$85K/Year (Based on experience) Skills & Experience * Bachelor’s degree in Electrical Engineering (or equivalent) with 5+ years in process automation * Strong troubleshooting and multitasking abilities with solid organizational skills * Proficiency in Visual Basic, Python, or other higher-level languages * Experience with relational databases (Microsoft SQL) and Windows OS/Server administration * Hands-on knowledge of PLCs and hardware (Siemens, Rockwell) What Makes You a Great Fit * Experience with sterile production equipment or pharmaceutical systems * Familiarity with industrial platforms (Client iFix, Rockwell FactoryTalk, XL Reporter) * Knowledge of aseptic processes, hydraulics, pneumatics, motor controls, and related electrical systems ABOUT US: PrideNow is Pride Global's light industrial staffing organization, a distinguished division within the Pride Global umbrella. Aligned with the overarching mission of Pride Global, we specialize in delivering top-tier human resources and workforce solutions to the light industrial industry. Leveraging the strength of our global network, PrideNow is dedicated to empowering diversity, ensuring compliance, and driving unparalleled success for businesses. As part of the Pride Global family, we bring forth a commitment to excellence and a comprehensive approach to meeting the unique staffing needs of our clients worldwide. Welcome to PrideNow, where our local expertise seamlessly integrates into the global excellence of Pride Global, shaping a future of dynamic workforce solutions. BENEFITS DISCLOSURE: Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - offer eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors. EEO STATEMENT: As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.

Job Description Job Title: Scientist, Production Reports To: Principal Scientist or Supervisor Position Location: Buffalo, NY FLSA Status (Exempt/Non-Exempt): Non-Exempt Position Summary: Individuals serving in this position will be working in both manufacturing, product development, and QC testing at the ZeptoMetrix business unit. Employees will be trained in a variety of lab techniques specific to the department assigned as well as document generation and completion. Key Responsibilities: • Execution of quality system procedures, • Proper execution of SOPs and work instructions for manufacturing procedures assigned by supervisor, • Ability to work individually as well as part of a team towards completion of specific projects, • Use of manufacturing related equipment as required by work instructions and SOPs, • Data analysis, • Demonstration of sound problem-solving skills and troubleshooting abilities, • Adherence to quality systems with special regard to FDA, ISO 13485 and GMP / OSHA compliance, • QC testing of components and finished products, • Inventory management of materials and supplies, • Focus on continual process improvement, • Cleaning and maintenance of equipment, • Guided experimental design and product testing assigned by supervisor, • Preparation of reagents, media, and buffers, • Performs other duties as assigned Candidates will participate in one of our following Departments. Department Specific Potential Duties: Immunology • Test kit assembly including dispensing and product labeling Virology • Use of aseptic technique in a Biosafety Cabinet to perform cell culture, viral infections, harvests, processing, and QC testing for the manufacture of products from raw materials and cell culture components., • Proper use of PPE and safety protocols in BSL-2 and BSL-3 containment laboratories. Bacteriology • Growth and manipulation of multiple microorganisms including bacteria, fungi, parasites, and bacteriophages for product manufacturing., • Proper use of PPE and safety protocols in BSL-2 and BSL-3 containment laboratories Molecular • Use and understanding of molecular biology methods and applications., • Manufacture of molecular controls/panels using aseptic technique., • Operation of real-time PCR equipment and sample to result platforms. Education: • 4-year B.S. degree required in biology, microbiology, or other life sciences program Experience: • Relevant experience in laboratory skills/cGMP preferred. Including but not limited to pipetting, preparing reagents, centrifugation, recording observations, etc., • Understanding of molecular biology techniques Minimum Requirements/Qualifications: • Ability to analyze and interpret data and results, • Proficiency in Microsoft Office, • Strong analytical, problem solving, process improvement skills, • Attention to detail, • Ability to multitask and adapt to changing priorities, • Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints, • Excellent communication skills, both written and verbal, to communicate to all levels of the organization clearly and concisely, • Strong work ethic and an ability to excel within a rapidly changing and growing organization, • Willingness to cross train and support other teams as needed for our medium sized business., • This position does not have any direct reports but serves as a coach and mentor to peers across the organization. Salary Range: $50,000 - $60,0000, depending on location and experience. This position has not been approved for Relocation Assistance. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Job DescriptionJob Title: Director of Quality and RegulationLocation: Buffalo, NYHire Type: Direct HirePay Range: $180k plus bonusWork Model: Onsite, Monday–Friday, Flexible 8:00 AM – 5:00 PM Recruiter Contact: Samantha Marranca | 716-256-1271 | & Scope:Positional OverviewWe are seeking an experienced Director of Quality & Regulatory to join the executive leadership team. This role will be responsible for developing and implementing the strategy, systems, and standards for the quality and regulatory function, ensuring compliance with all applicable legal and industry requirements. The successful candidate will collaborate with leadership peers across Manufacturing, Supply Chain, R&D, HR, and other key functions to drive quality excellence and ensure adherence to cGMP, FDA, EPA, OSHA, and other regulatory standards.Role & Responsibility:Tasks That Will Lead To Your Success • Provide leadership for the site’s quality and regulatory function as part of the executive leadership team., • Develop and oversee systems, policies, and standards to ensure compliance with cGMP, FDA, EPA, OSHA, and related requirements., • Establish and maintain SOPs, internal audit programs, and training initiatives., • Manage the Quality Laboratory and support Environmental Health & Safety compliance., • Ensure adherence to customer quality requirements and implement corrective actions for any deviations., • Oversee quality control and assurance systems, investigating failures and driving timely resolutions., • Lead inspections of incoming goods (raw materials, components, finished goods) in compliance with agreed standards., • Direct monthly site audits, reporting results to leadership and ensuring corrective actions are taken., • Audit and manage suppliers to confirm compliance with established standards., • Partner with Manufacturing and R&D to ensure product quality across all production batches., • Serve as point of contact for 3rd party, government, and independent audits., • Review and approve packaging labeling for compliance with regulations and substantiation requirements., • Represent the company with professional organizations and industry groups., • Lead, mentor, and develop staff across the quality and regulatory function, including direct and indirect reports. Skills & ExperienceQualifications That Will Help You Thrive, • BS/BA degree required., • 10–15 years of experience in quality and regulatory functions within a manufacturing environment., • In-depth knowledge of FDA cGMP regulations and ISO standards., • Proven experience managing compliance with regulatory agencies., • Expertise in OTC monographs, labeling, and claim substantiation., • Strong communication skills with the ability to influence cross-functional teams., • Demonstrated leadership in managing, training, and developing staff.

Job Description Job Title: Full Time Mammography Technologist Reports to: Mammography Manager Status: Non-Exempt Pay: To determine our range, we consider as many of the following data points as are available to us: external market salary survey data, internal data in terms of comparable roles and our budget for the position. What we have posted is our good faith estimate of what we expect to pay: $30-$36 an hour. Summary: The Mammography Technologist works as a member of the Mammography team, reporting to the Mammography Manager. This role provides X-ray based imaging to patients and supports the patient experience throughout their time at GLMI. Effective communication between departments and exemplary patient care must be maintained. This role performs a variety of tasks beyond Mammography imaging including; patient calls, documentation in charts, and assisting with both patient and other co-worker needs. Our Values: As a member of the team at GLMI it is expected that you embody the Great Lakes Way in your daily actions here. Personalize the Experience • Greet with eye contact and share a smile., • Create a tone of friendliness and warmth in conversations with patients, peers, and associates., • Respectfully interact with patients, peers, and associates at their pace and level., • Take time to listen to and understand others., • Demonstrate patience and compassion when interacting with patients, peers, and associates., • Do what you say you will do., • Anticipate and prevent potential problems., • Be responsible and efficient with Great Lakes resources (time, scheduling, property, equipment, etc.)., • Follow up on inquiries promptly and accurately., • Take personal responsibility for your work area and the quality of your work., • Speak positively about Great Lakes, team members, and patients., • Demonstrate respect and attentiveness to team members when communicating., • Recognize and share successes of the Great Lakes Way in action., • Proactively offer to help others., • Be flexible and embrace change with a positive attitude., • Contribute to a fun, energetic, and positive work environment., • Share information, knowledge, and expertise., • Be relentless about acting on opportunities to learn and improve., • Ask for, accept, and use feedback., • Operate mammography unit to produce images of the breasts for diagnostic purposes under direction of the Physician, • Pre-screen patients to include taking patient history and vitals., • Provide a clear and thorough explanation of procedures to patients., • Ensure outside images are obtained prior to the study and coordinates the report addendum from the Radiologist once images arrive., • Document patient history and forward it to the Radiologist., • Position patients and immobilize areas of interest in the unit and place markers where appropriate., • Monitor patients throughout the exam to ensure patient safety and comfort., • Critique images before being sent to the Radiologist., • Coordinate any additional studies needed to obtain a thorough and complete exam., • Call patients with results when necessary., • Collect samples for patient genetic testing and schedule office visits when needed., • Perform Stereotactic biopsies., • Assist with ultrasound guided biopsies., • Observe radiation safety procedures to safeguard against overexposure of patients and personnel to radiation., • Respond to patient concerns in a timely and professional manner., • Disinfect mammography machine and exam room after each patient., • Maintain, monitor and restock various medical supplies as needed., • Perform quality assurance in accordance with FDA and MQSA guidelines., • Perform Bone Density exams., • Attend all required staff meetings, training seminars and other designated meetings., • Overtime may be required, as needed., • Ability to perform each duty as listed above., • Strong computer skills including use of information systems and Google based programs., • Problem solving skills, • Strong oral communication skills including both phone and in person., • Strong customer service skills., • Experience in radiology or medical terminology preferred, • Associates degree or higher preferred or equivalent experience, • Have and maintain ARRT and NYS licensing requirements including continuing education credits., • CPR certification, • Knowledge of applicable patient positioning and technique for modality., • May be asked to lift up to 35 pounds, • Standing, walking, sitting, keyboard use for long periods of time, • Ability to listen and communicate with patients face to face or over the phone, • Will be required to read, write, work in a fast-paced office setting, • Ability to make decisions and think quickly, • Must have mental and physical capabilities to perform all tasks listed above Job Posted by ApplicantPro

I am a recruiter with a medical device designer/developer and manufacturer of a cutting edge intelligent infusion device that is Bluetooth enabled. We seek a top-flight Director of Software Development from a medical device company to join our team. Position Summary We are seeking a Senior Software Manager/Director with deep experience in embedded systems and connected device ecosystems. This role will lead a multidisciplinary team developing regulated embedded medical devices that interface with cloud infrastructure and/or mobile applications. The ideal candidate brings hands-on embedded expertise, a strong systems engineering mindset, and a track record of managing full software lifecycle development in compliance with IEC 62304 and FDA regulations. Key Responsibilities • Lead and mentor a team of embedded software engineers, systems engineers, and test engineers., • Drive architecture, design, development, and validation of embedded software in complex medical devices., • Manage the delivery of software components that interact with cloud platforms and/or mobile applications., • Ensure compliance with regulatory standards, particularly IEC 62304, ISO 14971, ISO 27001, and FDA 21 CFR Part 820., • Define and enforce software cybersecurity controls, configuration management, and access protocols., • Own the technical roadmap, design reviews, code reviews, integration strategy, and test coverage across embedded platforms., • Collaborate cross-functionally with Systems, Electrical, Mechanical, Quality, and Regulatory teams to deliver safe, effective, and high-quality software., • Oversee and improve the use of tools and processes for configuration management, integration testing, and automated builds/releases., • Participate in hazard analyses and risk management reviews related to software. Required Qualifications • Bachelor’s or Master’s degree in Computer Engineering, Software Engineering, Electrical Engineering, or related field., • 10+ years of experience in embedded software development., • 5+ years of technical leadership or software management experience., • Proven experience with embedded Linux, RTOS, microcontroller platforms (ARM, STM32, etc.)., • Prior experience leading development for Class II or Class III medical devices., • Direct experience with medical device development under IEC 62304 and FDA design control processes., • Experience managing products involving IoT/cloud connectivity or mobile application interfaces., • Strong grasp of system-level design and integration, including hardware/software co-development., • Working knowledge of cybersecurity risk assessment, secure boot, encryption, authentication, and network security controls., • Hands-on experience with integration testing frameworks, version control (e.g., Git), and CI/CD/CT pipelines., • Excellent communication, project planning, and cross-functional collaboration skills. Preferred Qualifications • Experience with over-the-air (OTA) update systems, Bluetooth, Wi-Fi, or cellular-connected devices., • Familiarity with tools like Jira, Jenkins, Docker, Yocto, and static code analysis tools., • Certification or training in cybersecurity standards such as UL 2900, ISO 27001, or NIST 800-53. What We Offer • Opportunity to shape next-generation medical technology., • Work with a passionate and experienced team across software, systems, and regulatory., • Competitive compensation and benefits., • A fast-paced, collaborative environment focused on innovation and quality. Prefer someone already living in the Buffalo/Rochester, NY area, but will consider hiring someone from outside the area, based on your experience. Ideally, someone from an infusion device company.

Job Description Field Services Support Technician We’re seeking a skilled Field Service Technician to join our global service team. In this role, you’ll perform preventive maintenance, troubleshooting, and commissioning of advanced freeze-drying systems installed worldwide. When not traveling, you’ll support equipment testing, production, and customer service operations at our facility. Key Responsibilities • Perform global preventive maintenance and service on freeze-drying systems, • Diagnose technical issues and implement effective solutions, • Support commissioning, testing, and production activities, • Maintain detailed and accurate service records, • Provide on-call support per customer agreements, • Technical degree or certification in electromechanical or process engineering, • 3–5 years of experience installing and maintaining industrial equipment, • Strong knowledge of PC/PLC-based control systems (SCADA), • Ability to read and interpret mechanical and electrical schematics, • Hands-on troubleshooting of complex automated systems, • Experience in FDA-regulated or similar environments, • Knowledge of freeze-drying processes and equipment, • Willingness to travel frequently and provide on-call support, • Proven customer service and problem-solving mindset It is the policy of GCR to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. GCR is an Equal Opportunity/Affirmative Action Employer and embraces diversity in our employee population. Company DescriptionGCR is a national technical recruiting firm. We specialize in contract, contract to hire, and permanent staffing solutions across a variety of industries including, Information Technology, Commercial, Automotive, Semiconductor, Medical Device, Pharmaceutical, Manufacturing, and Defense.GCR is a national technical recruiting firm. We specialize in contract, contract to hire, and permanent staffing solutions across a variety of industries including, Information Technology, Commercial, Automotive, Semiconductor, Medical Device, Pharmaceutical, Manufacturing, and Defense.

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