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Job Description A Trusted CRO Partner for the Future of Eye Care iuvo Clinical is a full-service ophthalmology-focused contract research organization (CRO) dedicated to improving patient’s quality of life with breakthrough eye care therapies. We combine decades of specialized experience with a high touch, high science approach, partnering with innovators to accelerate ophthalmic breakthroughs from concept to commercialization. Whether advancing a novel retinal therapy or supporting a complex ocular device trial, we provide the expertise, flexibility, and personal dedication to ensure clinical trial success. We offer a comprehensive benefits package and the opportunity to broaden your experience and grow your career! We currently have an exciting opportunity for a Site Relationship Manager to join our team! The Site Relationship Manager (SRM) is responsible for developing, maintaining, and strengthening relationships with clinical trial sites to ensure a reliable, high performing site network, enrollment performance, high-quality study execution, and long-term strategic collaboration. This role serves as a key liaison between investigative sites and iuvo’s clinical operations teams, supporting site engagement, feasibility, startup, and ongoing study performance. ESSENTIAL DUTIES AND RESPONSIBILITIES Site Relationship Management • Act as primary CRO contact for investigator networks, academic centers and private research groups., • Develop and maintain executive-level relationships at large site groups (e.g., multi-site ophthalmology) Site Network Development • Identify and onboard new sites and site networks, • Maintain databases of site capabilities, indications, and performance, • Segment sites (high-enrolling, specialty, early-phase, global, etc.) Site Performance Optimization • Monitor site-level performance metrics including enrollment, data quality, and compliance., • Collaborate with Clinical Study Managers (CSMs), CRAs, and project teams to improve site productivity., • Proactively identify enrollment barriers and implement mitigation strategies., • Analyze historical metrics:, • Enrollment rates, • Screen failure, • Data quality, • Query resolution times, • Flag underperforming sites early to operations, • Support rescue strategies for underperforming sites. Site Engagement & Retention • Keep sites loyal to the CRO through:, • Regular communications, • Investigator advisory boards, • Newsletters, webinars, training events, • Reduce site churn across multiple sponsors Feasibility & Study Placement • Lead or support feasibility assessments and site identification activities., • Provide insights into site capabilities, patient populations, and therapeutic expertise., • Contribute to site selection strategy aligned with sponsor requirements., • Support Business Development by:, • Matching studies to the right sites, • Advising on realistic enrollment projections, • Identifying competitive landscape risks Develop Preferred Site Programs • Negotiate master agreements, pre-qualify sites and create “ready-to-go” pools for rapid startup. Cross-Functional Collaboration • Partner with Clinical Operations, Study Start-Up, and Business Development teams., • Support bid defense meetings by providing site intelligence and relationship insights., • Assist in strategic site partnership initiatives. Quality & Compliance • Ensure adherence to ICH-GCP, regulatory requirements, and company SOPs., • Facilitate communication regarding protocol amendments, compliance updates, and training needs., • Support audit readiness and inspection preparation where applicable. QUALIFICATION REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. EDUCATION and/or EXPERIENCE: • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or related field required., • 5+ years of experience in clinical research required, • Experience as a CRA, Clinical Study Manager, or Site Engagement Specialist preferred., • Prior experience working in a CRO environment., • Demonstrated experience managing investigator relationships., • Knowledge/experience working in ophthalmology therapeutic area strongly preferred COMPUTER SKILLS: • Proficiency with CTMS and clinical trial systems., • Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable. COMMUNICATION SKILLS Effective verbal and written communication skills required to interact with clinicians, clients, vendors, FDA Inspectors and internal project team members through demonstration of: • Excellent presentation and interpersonal skills, including clear, succinct, and timely communication, • Sharing ideas in a constructive and positive manner, • Listening to and objectively considering ideas and suggestions, • Keeping commitments, • Keeping others informed of work progress, timetables and issues, • Addressing problems/issues constructively to find mutually acceptable solutions, • Respecting the diversity of our workforce in actions, words, and deeds, • Read and comprehend work instructions/SOPs and protocols and write clear concise reports OTHER SKILLS and ABILITIES • Thorough understanding of Good Clinical Practice, ISO standards applicable to given studies, and FDA regulations regarding conduct of clinical studies, procurement of informed consent, and IRB responsibilities., • Strong working and speaking knowledge of applicable therapeutic area terminology., • Must be highly organized, able to efficiently schedule and execute follow-up of tasks, manage multiple priorities, demonstrate strong attention to detail and analytical skills., • Strong relationship-building and stakeholder management skills., • Excellent communication and negotiation abilities., • Data-driven mindset with ability to interpret performance metrics., • Superior organizational and project management skills. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to sit or stand at a desk, talk and hear. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Office setting / remote home office. iuvo Clinical fosters a video-first environment; employees are expected to have their cameras on for all internal and external meetings, check-ins, and collaborative sessions. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. LOCATION Remote TRAVEL 25-40% travel DISCLAIMER This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. iuvo Clinical is an Equal Opportunity Employer

Job Description Allient-Rochester (formerly ORMEC Systems, Inc.), a subsidiary of Allient Inc., specializing in motion control systems, including motion controllers, servo drives, motors, and integrated automation solutions is seeking a Director of Operations to join our team in Rochester, New York! Allient-Rochester services the aerospace & defense, medical, semiconductor equipment, e-mobility & logistics, factory & industrial automation, and packaging industries, Allient-Rochester’s tradition of innovation and excellence in motion control continues to grow as part of Allient’s global network of specialized motion and control solutions. We are seeking an experienced and strategic Director of Manufacturing Operations to oversee the end-to-end manufacturing, supply chain, and quality operations for high-reliability power electronics and control systems. This senior leadership role is essential for delivering mission-critical products to highly regulated industries, including semiconductor equipment, medical devices, and aerospace/defense, where precision, compliance, and reliability are paramount.The ideal candidate will act as a "player-coach," blending high-level strategic oversight with hands-on operational management to drive efficiency, mitigate risks, and foster a culture of continuous improvement. This position ensures seamless integration across production, supplier management, and regulatory compliance, aligning with organizational goals for quality, cost, and delivery. Apply now! Responsibilities: • Oversee daily operations of electronics assembly, final box build, functional testing, and burn-in processes to ensure 100% reliability of power electronics and control units built to IPC standards (e.g., IPC-A-610 and J-STD-001)., • Manage the value-add engineering panel and sub-assembly shop, translating custom engineering requirements into high-quality products while optimizing labor, equipment, and resource utilization to handle fluctuating demand across market sectors., • Develop and implement production schedules, strategies, and process improvements to meet targets, reduce cycle times, and eliminate waste in a high-mix, low-to-medium volume environment., • Lead the Quality Management System (QMS), including internal audits, Corrective and Preventive Actions (CAPA), and continuous improvement initiatives., • Serve as the primary lead for maintaining and renewing ISO 9001:2015, ISO 13485, and/or AS9100 certifications, ensuring audit readiness and representation during external registrar or customer audits., • Enforce cascading requirements, such as "Copy Exact!" (CE!) protocols for semiconductor clients, flow-downs of contractual terms, and adherence to industry standards like FDA, NADCAP, and customer-specific regulations., • Manage strategic relationships with Tier 1 and Tier 2 suppliers, including identification, auditing, and oversight for critical components, PCBA fabrication, and services., • Direct all materials management, including procurement, shipping/receiving, kitting, inventory control (e.g., cycle counting and warehouse organization), and alignment with production schedules to prevent bottlenecks., • Develop risk mitigation strategies for long lead times, component obsolescence, and supply chain disruptions common in the power electronics industry., • Lead multi-disciplinary teams across production, engineering, logistics, procurement, and quality functions, fostering collaboration and professional development., • Champion Lean Manufacturing, Six Sigma, and other initiatives to enhance competitive positioning, profitability, and customer satisfaction while maintaining safety and regulatory compliance., • Manage budgets, analyze manufacturing execution issues, and implement solutions to ensure consistent product delivery and operational excellence. Minimum Qualifications: • 8+ years in operations or manufacturing management within the electronics industry, with a proven track record in power electronics, industrial controls, or similar high-reliability products., • Deep technical knowledge of power electronics (high voltage/current), control systems, electronic test methodologies, and standards like IPC-A-610., • Experience in highly regulated industries such as semiconductor (Copy Exact), medical (FDA/ISO 13485), or aerospace/defense (AS9100/NADCAP)., • Direct experience managing ISO certifications, rigorous change control, and QMS oversight., • Demonstrated leadership in managing cross-functional teams and proficiency in ERP/MRP systems (e.g., MS Dynamics, SAP, Oracle, or NetSuite)., • Bachelor's degree in Engineering, Supply Chain Management, or a related technical field; advanced degree (e.g., MBA) preferred., • Lean Six Sigma Green or Black Belt certification preferred, • Strong understanding of soldering and inspection standards (e.g., J-STD-001) preferred, • Familiarity with advanced manufacturing technologies and strategies for scaling operations in electronics manufacturing preferred. Work Environment: • This role involves a combination of office-based strategic planning and hands-on oversight on the manufacturing floor, which may include exposure to noise, chemicals, and machinery requiring personal protective equipment (PPE)., • Occasional lifting or handling of equipment up to 50 lbs may be required, along with standing or walking for extended periods., • Travel (up to 20%) may be necessary for supplier audits, customer meetings, or industry conferences., • The position is primarily onsite to support operational needs, with potential for limited hybrid flexibility depending on business requirements Don't let this opportunity pass you by - APPLY TODAY! To learn more about Allient Inc. visit www.Allient.com Allient 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. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training

Job Description See your work in a new light. At LUX Infusion, we're reimagining infusion care to be more human, supportive, and connected. Inspired by lux—meaning light - we guide patients, providers, and partners through complex therapies with clarity, compassion, and confidence. As a clinician-led, U.S.-based organization, we put people first - helping patients feel seen and supported through faster therapy starts, dedicated care coordination, and meaningful collaboration. Our commitment to inclusion, diversity, equity, and advancement (IDEA) is central to our culture, ensuring every team member feels valued and empowered to make a difference. Location: Rochester, NY (On-Site) Schedule: Monday – Friday | 8:30 AM – 5:00 PM EST, On-call rotation Schedule and work location may be adjusted based on business needs. Job Description The Clinical Pharmacist is responsible for ensuring safe, compliant, and effective pharmacy operations while delivering high-quality patient care. This role includes prescription verification, clinical review of patient therapies, medication dispensing, and patient counseling within BioMatrix Specialty Pharmacy and Centers of Excellence. The Clinical Pharmacist partners cross-functionally with internal teams, including Reimbursement, Nursing, Intake, and Pharmacy Operations, to support optimal patient outcomes and ensure seamless medication management. Key Responsibilities • Review and verify prescriptions for accuracy, appropriateness, and compliance, • Evaluate patient records to ensure safe and effective medication therapy, • Provide patient counseling on specialty medications and treatment plans, • Monitor drug therapies and recommend clinical interventions as needed, • Detect therapeutic duplications, interactions, and contraindications, • Oversee and validate pharmacy technician activities and documentation, • Collaborate with internal teams to support patient onboarding, referrals, and prescription fulfillment, • Ensure compliance with all federal, state, and accreditation standards (HIPAA, FDA, DEA, ACHC, URAC, etc.), • Support workflow efficiency across intake, dispensing, and delivery processes, • Serve as a clinical escalation point for patient care and prescription-related issues, • Maintain accurate pharmacy records, documentation, and reporting, • Participate in quality improvement initiatives and regulatory audits, • Provide training and mentorship to pharmacy staff, interns, and technicians, • Participate in on-call rotation as required Required Qualifications • Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy from an ACPE-accredited program, • Active, unrestricted pharmacist license in the state of New York, • Strong knowledge of specialty pharmacy therapies and patient qualification processes, • Experience delivering high-quality customer service to internal and external stakeholders, • Proficiency in Microsoft Office (Word, Excel, PowerPoint) Preferred Qualifications • 3+ years of pharmacy experience (Specialty, Infusion), • Experience supporting specialty pharmacy operations and patient care coordination, • Knowledge of payer requirements, reimbursement processes, and specialty drug access, • Experience working collaboratively with pharmacy technicians and interdisciplinary teams, • Familiarity with CareTend or similar pharmacy management systems, • Certification in Good Clinical Practices (GCP) Core Competencies • Strong clinical judgment and attention to detail, • Ability to manage multiple priorities in a fast-paced environment, • Effective communication and cross-functional collaboration skills, • Analytical thinking with a proactive, solutions-oriented approach, • Leadership ability to guide, mentor, and support team members, • Commitment to compliance, quality, and patient-centered care Additional Requirements • Ability to work flexible hours and overtime as needed (exempt role), • Occasional travel may be required, • Maintain all required licensure and continuing education, • Participate in performance improvement and quality assurance initiatives Pay Range/Rate$130,000—$140,000 USDPHYSICAL DEMANDS The physical demands described here represent those required for an employee to successfully perform the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. If you require a reasonable accommodation during the application or interview process, please contact the LUX Infusion Talent Team at Careers@LUXInfusion.com or 954.385.7322 x 1425. While performing the duties of this position, the employee may occasionally be required to stand, walk, or sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch, or crawl; and talk or hear. The employee may also be required to occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this role include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. OTHER REQUIREMENTS Employees are expected to: • Participate annually in required legal and ethical compliance training, • Consistently act in compliance with LUX Infusion's legal, ethical, and compliance policies, • Adhere to all standards and procedures outlined in the LUX Infusion Compliance Manual, • Refrain from any behavior that could be considered unethical or unlawfulEXPECTATIONS FOR ALL EMPLOYEES All LUX Infusion team members are expected to support the organization's mission, vision, and values by demonstrating integrity, dedication, compassion, and enthusiasm. This includes placing patients first, working collaboratively with a "stacked‑hands" mindset, and maintaining a consistent focus on quality, accountability, and continuous improvement. GENERAL INFORMATION The statements above are intended to describe the general nature and level of work performed by individuals in this role. They are not intended to be an exhaustive list of all responsibilities, duties, or skills required. This role operates in a fast‑paced environment and requires the ability to prioritize competing demands, manage multiple tasks effectively, and seek guidance when appropriate. Employees in this position may be required to assist directly - or coordinate appropriate assistance - to ensure access to LUX Infusion's services for individuals with disabilities, including patients, visitors, employees, or others. LUX Infusion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Job Description Job Title: Packaging Technician Reports To: Packaging Supervisor Hourly Rate: $18.00 Location: 350 Buell Rd., Rochester, NY 14624 Position Overview The Packaging Technician is responsible for the safe, accurate, and efficient packaging and labeling of food-grade cannabis products. This role requires maintaining cleanliness, ensuring quality and consistency, and following Good Manufacturing Practices (GMP). The Packaging Technician will support the packaging department by maintaining proper records, assisting with inventory management, and performing other tasks as assigned by management. Essential Duties and Responsibilities• Package and label cannabis products in accordance with company protocols and training. • Accurately label all packaging to ensure regulatory and brand compliance., • Fulfill production and sales orders efficiently and with high attention to detail., • Ensure packaging meets established quality and quantity standards., • Maintain accurate counts of inventory and assist in tracking raw materials, packaged goods, and fulfilled orders., • Move product inventory safely between work areas., • Keep workstations organized, sanitized, and compliant with safety and sanitation standards., • Track and dispose of waste material in accordance with company procedures., • Comply with all biosecurity and hygiene measures within the facility., • Maintain up-to-date knowledge of state regulations, compliance requirements, and company SOPs., • Participate in required training and professional development activities., • Support other departments and tasks as needed, demonstrating flexibility and teamwork., • Maintain consistent attendance and punctuality., • Adhere to all company policies, procedures, and safety protocols. Minimum Qualifications • High School Diploma or GED required., • Minimum of 1 year of experience in a manufacturing or packaging role with a focus on product safety, quality, and compliance., • Familiarity with FDA, GMP, HACCP, OSHA standards (preferred)., • Ability to wear all required PPE, including bump cap, hairnet, earplugs, beard net (if applicable), gloves, safety glasses, and slip-resistant shoes., • Basic computer literacy and math skills., • Strong communication skills and attention to detail., • Dependable with a strong work ethic and willingness to learn., • Ability to perform repetitive tasks for extended periods of time., • Ability to push, pull, or lift up to 50 lbs.• Must have reliable transportation. Working Conditions and Physical Requirements • Exposure to environmental elements including dust, fumes, temperature extremes, humidity, and noise., • Exposure to physical risks involving mechanical, chemical, and electrical hazards., • Requires standing, walking, bending, kneeling, reaching, and lifting throughout the shift., • Must be able to lift and carry up to 50 pounds., • Must be able to use fine motor skills and perform detailed, repetitive tasks., • Frequent interaction with team members, supervisors, and vendors, requiring professional communication and etiquette., • High stress tolerance and adaptability in a fast-paced, changing environment. Expectations • Embody and uphold the company's Core Values of People, Quality, and Growth., • Flexibly support other areas of the facility as needed., • Complete all required training on schedule., • Maintain full compliance with company policies and procedures. Equal Opportunity Employer The company is proud to be an Equal Opportunity Employer and complies with all applicable ADA regulations.

Akkodis is seeking a Senior Database Design Engineer, C++ job with a client in Rochester, NY. Must hold a B.S. Degree in Computer Science, Computer Engineering or a related discipline to be considered. You will focus on the design and implementation of robust applications for distributed Linux-based software systems while leading efforts in database schema and integration. Collaborate with system architects, middleware developers, and UI teams to ensure database access patterns are well-defined, testable, and stable. Salary Range: $100/k to $120/k. The salary may be negotiable based on experience, education, geographic location, and other factors. Senior Database Design Engineer, C++ responsibilities include: • Serve as the database architecture owner for PostgreSQL or equivalent database instances embedded within medical devices running Linux on workstation-class hardware., • Design relational schemas, views, indexes, and constraints that balance performance, maintainability, and regulatory traceability., • Own and maintain the database design over time, including governance of schema changes, technical debt management, documentation, and coordination of design evolution across releases., • Act as the central design authority for how multiple software components read from and write to shared database resources., • Design database interfaces and usage patterns that minimize the need for future migrations, while still enabling safe, versioned evolution when required., • Lead query optimization and performance tuning, including execution plan analysis, indexing strategy, and long-term capacity planning., • Define standards for database versioning, migration strategy, and backward compatibility suitable for regulated, fielded systems., • Provide technical leadership in design reviews related to data modeling, persistence strategy, and cross-process communication via the database., • Support backup, restore, and recovery strategies appropriate for on-device databases in production medical equipment., • Participate in requirements, architecture, design, verification, and validation activities within a regulated quality management system (FDA, IEC 62304, ISO 13485). Desired Qualifications: • B.S. Degree in Computer Science, Computer Engineering or a related discipline required., • Minimum Five years related experience, • Demonstrated expertise in designing and evolving relational schemas; optimizing queries through execution plan analysis; and defining indexing, view, and data-access layers that support multiple consumers., • Experience supporting on-device or embedded databases, where the database runs locally on a deployed system rather than as a managed cloud service., • Strong understanding of data evolution strategies, including migrations, versioned schemas, and backward compatibility., • Experience working in regulated or safety-critical environments (medical devices strongly preferred)., • Working knowledge of C++ or similar programming language sufficient to collaborate with application developers and review database interaction code. If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at 585-490-8656 or gina.manioci@akkodis.com Equal Opportunity Employer/Veterans/Disabled Benefits offerings include but are not limited to: • Medical/ Dental/Vision Insurance, • 401k, • Holidays and PTO To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit _. The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: · The California Fair Chance Act · Los Angeles City Fair Chance Ordinance · Los Angeles County Fair Chance Ordinance for Employers · San Francisco Fair Chance Ordinance

We're hiring a Quality Specialist to join our Kodak team in Rochester, NY. This role supports the implementation and maintenance of quality systems within a GMP regulated manufacturing environment. The near term focus is on executing quality system activities, supporting investigations, documentation, and inspection readiness under the direction of Quality Management. Longer term, this role will provide ongoing quality support to manufacturing as operations ramp and mature. This is a hands on role focused on quality system execution rather than full system ownership. Specific Duties and Responsibilities: • Support Quality Management during regulatory agency and customer audits and inspections., • Promote an ethic of quality in all aspects of the company’s related business activities by supporting GMP and quality requirements in day-to-day operations through consistent application of procedures and documentation standards., • Support activities related to the GMP Quality Management System (QMS), including execution of quality processes and maintenance of quality records., • Support execution and documentation of validation and qualification activities for facilities, equipment, GMP systems, and testing procedures under approved protocols., • Review test results and quality records for completeness and compliance prior to final approval by Quality Management., • Support maintenance of GMP facilities and equipment records, including calibration, maintenance tracking, and investigation of OOT or excursion events as assigned., • Assist in ensuring GMP personnel training is completed, documented, and current., • Support complaint handling activities, including documentation, investigation support, and follow up actions., • Participate in investigations related to deviations, CAPAs, incidents, OOS/OOT events, and support root cause analysis and corrective actions., • Support GMP Service and Technical Agreements administration as required., • Assist in maintaining the Approved Suppliers List and support qualification or requalification activities for suppliers., • Draft, revise, and maintain SOPs, controlled forms, and related quality documents under supervision to ensure best practices and alignment with current operations., • Support monitoring systems and activities that may impact GMP operations., • Support coordination with QC laboratory personnel as needed, including documentation review and alignment of GMP records., • Participate in internal audits of GMP operations and supporting processes, including sample handling, training, testing, reporting, and related LIMS activities., • Support efforts to ensure test procedures, standards, and specifications remain current with applicable domestic and international regulations., • Provide quality and technical support to cross functional teams as needed., • Perform additional duties and responsibilities as assigned by Quality Management. Qualifications (Education, Experience and Skills): • Bachelor’s degree is required in a scientific, engineering, or related technical discipline., • 3–5 years of related experience in an FDA regulated environment, such as medical devices or pharmaceuticals., • Working knowledge of GMP requirements, quality investigations, root cause analysis, CAPA, auditing principles, document control, and SOP development., • Experience supporting validation, laboratory operations, inspections, and quality system maintenance preferred., • Strong attention to detail, documentation skills, and ability to work effectively in a regulated manufacturing environment. Certifications Preferred: • cGMP, ISO Auditor, ASQ, or similar certifications preferred but not required.

Summary: The Quality & Process Supervisor ensures that Love Beets maintains safe food manufacturing practices and remains compliant with U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and Safe Quality Food (SQF) requirements, in addition to following our internal policies and procedures. STATUS: Full Time LOCATION: Onsite SCHEDULE: Monday-Friday Responsibilities: • Support the maintenance and development of the LBP Food Safety Plan, HACCP & HARPC based food safety plans LACF Food Manufacturing and the requirements to maintain an SQF System relevant to the site's scope of certification., • Manage the sanitation team and optimize sanitation procedures and training., • Assist in monitoring and enforcing food safety programs, policies, and procedures., • Develop new technologies for food safety training programs for staff., • Prepare and maintain accurate documentation and records related to food safety compliance., • Support internal teams to resolve food safety issues and drive continuous improvement., • Collaborate with internal development and marketing teams to initiate critical path and gate process to launch., • Assist in data collection and monitoring of key performance indicators (KPIs) and process parameters to ensure optimal performance and compliance with food safety standards., • Analyze current production processes and identify opportunities for improvement to enhance efficiency, reduce waste, and improve product quality., • Troubleshoot any issues related to process deviations or product quality and collaborate with teams to implement corrective actions., • Assist transition of new processes from concept through trial stages to full-scale production., • Conduct risk assessments and food safety evaluations for new items to ensure safety and quality standards are met., • Maintain detailed records of proposed projects, trials, formulations and other activities as they pertain to FS&Q and sanitation., • Assist in designing, implementing, and evaluating new manufacturing processes, equipment, and technologies, ensuring we have the right analytical tests to support operations., • Work with engineering and production teams to integrate new processes into existing production lines., • Serve as a key liaison between food safety & quality and operations to ensure all process development, current and new meet both safety and quality standards and documented., • Provide expertise and support in food safety matters during new process changes., • Stay up-to-date with industry trends, emerging technologies, and regulatory changes that may impact product development and food safety practices. Attributes: • Familiarity FDA, USDA and SQF., • Exceptional organizational skills, • Strong computer skills, • Excellent time management skills, • Good communication skills, both written and verbal, • Attention to detail, • Excellent problem-solving skills, • Strong decision-making skills, • Ability to communicate with all levels of employees, • Knowledge of food safety and quality rules and regulations, • Ability to independently recognize opportunities for improvement and act accordingly Minimum Qualifications • Bachelor of Science degree in an agricultural area PHYSICAL REQUIREMENTS: M - Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects; Requires frequent walking, standing or squatting. PAY RANGE: $60-70,000 based on experience. The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts. Love Beets Production is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.

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 Mechanical Film Manufacturing Engineer III to work in our manufacturing facility in Rochester, NY. The Mechanical Film Manufacturing Engineer III will provide engineering oversight of film coating equipment and supporting systems to effectively and efficiently maintain and reliably operate the manufacturing equipment on site. This role will have a strong focus on troubleshooting and managing mechanical systems and components throughout their lifecycle including repairs, replacements, and upgrades. This position involves collaboration with various departments to ensure product compliance and continuity, to manage supply chain risks, and to validate components all while upholding the companies core values in interactions with team members and reporting to the Engineering Manager. A successful candidate will play a vital role in the overall success of operations. This position also requires system and process assessment, control of operating and maintenance documentation including performance metrics, attainment of productivity and cost objectives in daily operation, and assisting in maintenance of all equipment as needed in assigned areas and field. This position will continuously assess the general condition and validated readiness of critical assets required to deliver high quality, safe, compliant, cost effective equipment processes without interruption. This position is in Rochester, NY. 40% Support Maintenance and Operations with troubleshooting and resolving electrical issues on current automated equipment. 20% Lead or support large capital projects for equipment upgrades or replacements as required. 20% Identify and develop improvements to maximize uptime while reducing maintenance costs and improving reliability, quality, productivity, and safety. 10% Author and revise controlled manufacturing documentation such as preventative maintenance and standard operating procedure documents per ISO9000 standards. 10% Develop and maintain effective lines of communication across departments to achieve plant maintenance and reliability goals. Other Duties: Prepare reports, summaries, and Capital Appropriation Request (CAR) protocols. Exercise independent judgement that leads to overall company objectives with long-term impact on program schedules. Compliance with local, state, and federal regulatory bodies including FDA, ISO, EPA, OSHA, DEP and DEA. Initiate, facilitate, and participate and in Lean activities including 5S and Kaizen events. Flexibility in work schedule along with off hours support as necessary. Personal Protective Equipment (PPE) as required by work area. Perform other work-related duties as assigned (Last bullet required in North America). The Key Stakeholders Internal Customers: Manufacturing Operations Supervisors and Managers, Cell Leaders, Site Administrative Support Personnel, Quality, Engineering, Operations and Maintenance team members. External Customers: Automation vendors, suppliers The Individual Required Skills: BS or MS in Mechanical Engineering or Mechanical Engineering Technology 3-5 years of engineering experience in manufacturing. Strong electrical aptitude with troubleshooting experience. Strong verbal and written communication. Ability to plan, analyze, review, and implement assignments without appreciable guidance. Ability to manage competing priorities in a results-driven environment. Ability to lead teams and meet project deadlines. Adept in "Good Manufacturing Practices" (GMP). Adept in Microsoft Office tools (e.g. Word, Excel, PowerPoint, etc.). Preferred Skills: Experience working in an FDA medical device manufacturing facility with associated FDA and ISO regulations. Experience with motor drive systems, process controls systems, manufacturing equipment and vision systems. The Work Environment Working around moving machinery. Protective equipment required (Ear protection, gloves, eyewear, safety shoes. The Physical Demands No strenuous physical activity is required, though occasional light lifting may be involved. Approximately 30% of the time is spent in meetings, collaborating with the team, or talking on the phone, and 70% is spent at a desk performing analytical work on a computer. Minimal travel is required. The 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 the facts and circumstances of each case. The salary range for this position is $89,000 to $115,000 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. Equal Opportunity Statement 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

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. The Senior Project Manager is a mid-level individual contributor responsible for managing defined projects and supporting broader programs within the medical diagnostics portfolio. This role ensures effective planning, coordination, and execution of project activities across functional teams. The Senior Project Manager plays a key role in driving project success through collaboration, problem-solving, and process discipline. This role will be onsite in Rochester, NY with the option for Hybrid work schedule. The Responsibilities Leads the execution of assigned projects within larger programs, ensuring delivery on time, within scope, and within budget. Collaborates with teams across R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance & Marketing to align project activities and helps resolve issues. Develops and maintains detailed project plans, timelines, and resource forecasts. Tracks progress and adjusts plans as needed. Identifies project risks and issues early while working with stakeholders to develop mitigation and resolution strategies. Maintain accurate project documentation and provide regular status updates to program leadership and stakeholders Ensures all program activities comply with relevant regulatory standards (e.g., FDA, ISO, etc.). Maintains accurate documentation and audit readiness. Translates business strategy into actionable program plans. Develops roadmaps, defines milestones, and manages interdependence across functions including R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance, and Marketing. Serves as the primary liaison between senior leadership and program teams. Facilitates communication, manages expectations, and ensures transparency across all levels of the organization. Identifies potential risks and implements mitigation strategies. Leads change management efforts to ensure successful adoption of program outcomes. Provides regular updates to senior leadership, including dashboards, KPIs, and executive summaries. Champions best practices in program management. Drives process improvements and contributes to the evolution of the business portfolio. Performs other work-related duties as assigned. The Individual Required: Proven track record of leading complex programs with cross-functional teams through a medical device phase gate process resulting in approvals or working in a regulated environment (e.g. FDA, ISO, etc.). Bachelor's degree in engineering, Life Sciences, Business, or related field. PMP certification required or equivalent demonstrated capability. 7+ years of experience in program/project management, preferably in medical devices, diagnostics, biotech, or healthcare technology. Proficiency in project management tools (e.g., MS Project, Smartsheet). Strong business acumen, highly analytical, and strategic thinking. Exceptional communication (verbal & written), negotiation, and influencing skills. Ability to summarize complex project and technical subject matter into concise oral and written communications to Executive Management. Knowledge of timeline and budget management, manufacturing design transfer, Risk Management & Design Control. General knowledge of R&D, Regulatory, Clinical Affairs, Quality and Operations activities as they relate to the development of a medical device or product. Demonstrates the ability to lead the program team from inception to product launch using corporate design control processes and procedures. Is able to tailor the design control processes & procedures to fit the specific project needs and circumstances. Ability to work cohesively with multi-disciplinary scientific working groups. Must be able to lead, manage, and communicate action items and results from and in meetings in a logical fashion. Excellent prioritization, organization, and the ability to multitask. Develop project execution strategy with the ability to independently manage ambiguity. Experience in QSR (Quality System Regulations) and ISO medical device standards as well as a working knowledge of current FDA, IVDD, and other regulations. Works independently with minimal guidance; influences across functions and levels. Leads initiatives with significant business impact. Solves complex problems requiring innovative thinking and cross-functional collaboration. Travel: Must be willing to travel up to 10% domestic and international. This position is not currently eligible for visa sponsorship. Internal Customers: Finance on budgeting and resource planning. Clinical Affairs for project deliverables. Quality Assurance for project activities, design transfer and risk management. Senior Management on project reporting and planning. Interacts with Marketing on project deliverables. Regulatory and Clinical Affairs on project deliverables and planning. Operations and R&D External Customers: Third-party vendors and suppliers Project-specific development partners The work environment is a combination of laboratory, manufacturing, office, & remote home office. No strenuous physical activity, though occasional light lifting of files and related materials is required. 60% of time in meetings, working with team, or talking on the phone, 40% of the time at the desk on computer, doing analytical work. Occasional domestic and international travel required. Travel includes airplane, automobile travel and overnight hotel. The 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. The salary range for this position is $120,000 to $160,000. 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-AC1

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. The Role At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. We are seeking an accomplished and visionary Vice President of Clinical Affairs to lead the global clinical strategy and operations department for a rapidly growing diagnostics company focused on infectious disease, cardiology, and clinical laboratory innovation. This is a high-impact executive opportunity for a leader who has helped scale and commercialize successful IVD platforms and who is ready to shape the next generation of diagnostics. The Vice President of Clinical Affairs will lead all Clinical Strategy and Clinical Operations across the enterprise. They will be responsible for evidence generation and study execution across the company's infectious disease, cardiology, clinical laboratory portfolio, including molecular diagnostics, immunoassays, biomarkers, rapid testing, and point-of-care platforms. The ideal candidate will bring experience from a leading diagnostics organization and have a track record of creating and executing clinical evidence programs that resulted in regulatory approvals, market adoption, and commercial success. This role offers the chance to build strategy, influence enterprise direction, lead a high-performing organization, and bring meaningful diagnostic innovations to clinicians, laboratories, and patients worldwide. Location: This role may be performed remotely, with a preference for candidates located near our offices in San Diego, CA; Raritan, NJ; or Rochester, NY. The Responsibilities: Strategic Leadership • Develop and execute the global clinical affairs strategy aligned to pipeline and growth objectives., • Build integrated evidence-generation plans supporting FDA, IVDR, CE Mark, and international submissions., • Serve as a trusted executive advisor on clinical trends, competitive dynamics, and market opportunities., • Translate unmet customer needs from health systems, laboratories, and clinicians into actionable clinical priorities. Clinical Program Leadership • Lead multicenter pivotal trials, performance studies, usability studies, and post-market evidence programs., • Ensure high-quality execution across timelines, budgets, CRO management, and investigator relationships., • Interpret clinical data to support claims development, product positioning, and launch readiness. Infectious Disease & Cardiology Focus • Advance programs in respiratory disease, sepsis, bloodstream infection, antimicrobial stewardship, and emerging pathogens., • Lead evidence strategies for troponin, BNP/NT-proBNP, coagulation, and cardiovascular risk diagnostics., • Support clinical utility claims demonstrating workflow improvement, faster treatment decisions, and improved patient outcomes. Clinical Laboratory Partnership • Drive adoption strategies informed by real-world clinical laboratory operations and customer workflow needs., • Build relationships with hospital labs, integrated delivery networks, academic centers, and reference laboratories., • Ensure studies reflect implementation realities including throughput, staffing, quality systems, and utilization management. Scientific & Commercial Impact • Collaborate with Medical Affairs to develop and implement publication strategy, advisory boards, and KOL engagement., • Support market access and reimbursement evidence needs., • Partner with Commercial teams on evidence-based messaging and customer education. Team Leadership • Recruit, mentor, and retain top clinical affairs talent., • Build scalable processes, metrics, and organizational capability to support growth., • Foster a culture of urgency, accountability, collaboration, and excellence., • Perform other work-related duties as assigned. The Individual • PhD preferred with 10-15+ years of progressive leadership experience in Clinical Affairs, Medical Affairs, or Clinical Research within IVD or medical diagnostics., • Significant leadership experience within a top-tier diagnostics organization., • Demonstrated success leading studies supporting major product launches and regulatory approvals., • Experience across infectious disease, immunoassay, molecular diagnostics, cardiology, and/or core laboratory platforms., • Proven people leadership with experience managing global teams and external partners., • Deep understanding of FDA, IVDR, CLIA, CAP, GCP, and global diagnostics pathways., • Strong knowledge of clinical laboratory operations, workflow optimization, quality systems, accreditation, and customer implementation challenges., • Expertise in assay performance metrics, biomarker validation, and clinical utility evidence generation., • Strong executive presence with ability to influence board-level and enterprise stakeholders., • Commercial mindset with ability to connect clinical evidence to growth outcomes., • Entrepreneurial leader who thrives in a fast-paced, high-accountability environment., • Travel up to 30-40% visiting QO's design centers and supporting clinical trials, • This position is not currently eligible for visa sponsorship. The Key Working Relationships Internal Partners: • R&D, Regulatory Affairs, Quality, Medical Affairs, Market Access, and Commercial teams to accelerate product development and successful global launches External Partners: • Vendors and suppliers How We Work 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 The Work Environment If the work environment is mainly typically in the lab/warehouse/production line, use verbiage like: The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines. Travel includes airplane, automobile travel and overnight hotel; up to 30-40% domestically. Physical Demands No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation. Salary Transparency The 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 the facts and circumstances of each case. The salary range for this position is $300,000 to $350,000 and is bonus, equity / long-term incentive 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. Equal Opportunity 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 the 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-TO1

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 the company continues to grow, we are seeking an Automated Maintenance Technician II to work in our manufacturing facility. The technician will troubleshoot, repair, and set up moderately complex manufacturing equipment per applicable documentation. This position supports manufacturing in the timely repair of equipment and machinery to ensure line uptime and productivity. Addresses production maintenance demands timely to meet production schedules. Performs root-cause analysis, communicates recommendations, and implements solutions that prevent reoccurrence. Provides enhanced support to facilities maintenance and calibration. Participates in the transfer of new production lines. Provides input and technical support to new projects. This position is in Rochester, NY. Schedule: (4) 12 hour rotating shifts; (2) 12-hour days; (6am-6pm), (2) 12-hour nights (6pm-6am), 4 days off, plus crossover time. This position is in Rochester, NY. Troubleshoots and repairs equipment used in manufacturing and packaging areas. Reads and interprets equipment manuals and work orders to perform required maintenance and service. Performs routine and non-routine preventative maintenance in accordance with approved methods and documentation. Applies safety procedures to all work. Documents all work activities via CMMS. Flexibility in work schedule along with off hours support and coverage as necessary. PPE as required by area. Maintains and ensures neat and orderly work areas. Required: A minimum certificate or AAS in mechanical/electrical technologies or related field or completed an apprenticeship and/or formal automated equipment mechanic training. Equivalent combination of education and work experience may be considered. A minimum of 12 months relatable work experience. Knowledge of automated machinery and related subsystems is recommended. Ability to read and interpret prints and schematics, shop materials, and mechanical and electrical drawings. Strong Verbal and Written Communication. Carry out duties in compliance with all local, state, and federal regulatory bodies including FDA, EPA and OSHA. Adheres to all Company safety and site policies, procedures, and regulations. Required Travel: Less than 5%. Preferred: Familiarity with CMMS; Maximo experience highly desirable. Internal Partners: Manufacturing Operations and other product release laboratories: PAR (Performance Assignment and Release), Reference; Product Support, R&D, Complaint Handling Unit and Customer Technical Services. External Partners: College of American Pathologists, NGSP-University of Missouri (for certifications), CEQAL- Vancouver, BC (for certifications). The work environment characteristics are representative of a manufacturing and laboratory, environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 50% of time in meetings, working with team; 50% of the time at the desk on computer, walking, standing, or sitting extended periods of time, doing analytical work are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted. Flexible work hours to meet project deadlines. The 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 the facts and circumstances of each case. The salary range for this position is $50,000 to $66,000 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

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 Manger, Microbiology. The Manager, Microbiology 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 Quality Control-ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The Quality & Compliance Manager partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement. The Microbiological Testing Manager is responsible for the strategic oversight, technical leadership, and operational management of microbiological testing activities supporting the development, manufacture, release, and lifecycle management of in vitro diagnostic (IVD) products across a global organization. This role ensures that microbiological testing is scientifically sound, compliant with global regulatory requirements, and aligned with business and product quality objectives. 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 ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be onsite in Pompano Beach, Florida or Rochester, NY. 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. 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. Provide subject matter expertise in microbiological testing relevant to IVD products, including but not limited to sterility, bioburden, endotoxin, microbial identification, and environmental monitoring. Implement and maintain microbiological testing strategies to support product development, validation, manufacturing, and ongoing compliance. Ensure appropriate risk-based approaches are applied to microbiological controls throughout the product lifecycle. Lead and manage microbiology laboratories and/or external testing partners across multiple global sites. Ensure timely and accurate execution of testing to support manufacturing, batch release, and project timelines. Ensure team provide microbiological input to design reviews, risk assessments, supplier qualifications, and process validation activities. Ensure oversight within the team of laboratory investigations, deviations, OOS/OOT results, CAPAs, and change controls related to microbiological testing. Perform other work-related duties as assigned. Required: Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership. Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. 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: 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. Experience supporting or leading Health Authority or Notified Body inspections. Internal: Tech Transfer, Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, and other 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 required. 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 $102,000 to $133,000 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

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. The Role At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Staff Systems Engineer to support new product development. We are looking for a motivated Staff Systems Engineer for in vitro diagnostic instrument development who will provide technical leadership and contribution to product design for QuidelOrtho's instrument platforms. System Engineers at this level have extensive experience and expertise in the field of systems engineering. They possess in-depth knowledge of systems engineering principles, processes, tools, and are often involved in high-level planning, integration, and optimization of complex systems. This role requires advanced problem-solving skills, the ability to lead a smaller team on large-scale projects, and a commitment to ongoing professional development. Additional responsibilities may include management of large technical projects or processes that span outside the immediate job area. Work is performed with limited oversight. Position may include the management of a team of 1-5 junior systems engineers. This position will be onsite 4 days a week with one day remote in Rochester, NY. The Responsibilities • Gather, analyze, and manage system requirements, ensuring alignment with regulatory standards and customer needs, • Conduct risk analysis and mitigation strategies, including Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA)., • Lead formal design reviews; provide system-level perspective and ensure compliance with design controls., • Drive instrument development by creating a plan of execution using his/her knowledge and ability to derive unique solutions and approaches, which are cost effective and contribute to the success of the project., • Utilize modeling, simulation, and data analytics to assess system behavior and optimize design performance., • Diagnose and resolve system-level issues, ensuring timely delivery of solutions. Use system engineering tools to carry out Root Cause, • Investigations and determine corrective and preventative action plans., • Provide status updates as needed to senior leadership, highlighting progress, risks, and mitigation plans., • Responsible for making moderate to significant improvements of processes, systems or products to enhance performance of technical job area., • Apply Six Sigma methodologies to identify, analyze, and improve processes within the development and manufacturing of medical devices., • Develop and execute system level test plans and protocols to validate system performance, reliability growth, and safety, • Conduct statistical analysis to determine appropriate sample sizes for verification and validation activities, ensuring robust and reliable results., • Collaborate with key stakeholders and external design partners to deliver product features that improve our customer experience, product performance and safety., • Perform other work-related duties as assigned. The Individual Required: • Bachelor's Degree in System Engineering, Biomedical Engineering, or related engineering field with strong cross-discipline experience is required, master's degree preferred., • Minimum 8+ years relevant experience required with a track record of delivering products in the medical, automotive, and/or defense industries, preferably with relevant medical device design exposure., • Demonstrated experience using Six Sigma tools and techniques for process optimization and quality improvement, • Demonstrated experience in applying statistical techniques to real-world problems, particularly in the medical device industry., • Demonstrated experience in systems engineering tools and methodologies, as well as experience with software development, hardware design, reliability growth testing and systems integration., • Strong verbal and written communication skills, with the ability to convey complex technical information to diverse audiences., • Ability to work effectively in a collaborative, cross-functional team environment. Including the mentoring of more junior engineers., • Strong analytical and problem-solving skills, with a focus on delivering innovative solutions., • Must have strong customer focus to ensure that the experience delivered by the product is consistent with expectations., • Results orientation: Must be capable of making commitments, setting priorities, and delivering results in time and on budget in a highly regulated environment., • Situational Adaptability: Sees ahead clearly; can anticipate future concerns., • Develops and maintains effective cross functional relationships and is capable of quickly earning trust and respect., • Must have the ability to travel 10% both domestic and international., • This position is not currently eligible for visa sponsorship. Preferred: • Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, etc.), • Demonstrated experience in successfully working with external development partners in delivering complex solutions., • Familiarity with Clinical Chemistry and/or Immunohematology in vitro diagnostic instruments. The Key Working Relationships Internal Partners: • R&D Leadership, • Quality, • Regulatory, • Service, • Manufacturing, • Marketing, • Project Management External Partners: • Clinical chemistry and transfusion medicine personnel (current and potential customers), • Development partners How We Work 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 The Work Environment If the work environment is mainly typically in the lab/warehouse/production line, use verbiage like: The work environment characteristics are representative of a laboratory, or office environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines. Physical Demands No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel required. Travel includes airplane, automobile travel and overnight hotel. Salary Transparency The 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 the facts and circumstances of each case. The salary range for this position is $125,000 to $135,000 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. Equal Opportunity 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 the 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-TO1

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 Senior Manager, Design Quality (Hardware & Software). The Sr. Manager, Design Quality (Hardware & Software) 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 Design 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 leads a team of quality professionals that provide strategic direction and operational oversight across product design lifecycle with responsibility for overseeing Design Controls and Risk Management for hardware, software, and integrated IVD systems. The team also ensures that user needs, requirements and claims are translated into testable scientifically sound criteria. As the primary Quality partner for cross functional development teams, this role also guides the evaluation and approval of design changes, drives validation and claim verification strategies, and represents Quality in global audits. This role is responsible for ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). This position requires a blend of technical expertise, leadership capability, and the ability to navigate complex, fast paced environments while championing a proactive quality culture. The Quality & Compliance Manager/Senior Manager partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement. 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 Sr Manager, Design Quality (Hardware & Software) ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be onsite in Rochester, NY. 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. Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. Partner with R&D, Regulatory Affairs, Manufacturing, 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 team members 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 Perform other work-related duties as assigned. Required: Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries Demonstrated experience leading a small to mid-sized team of professionals, providing direction and oversight. Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. 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. Commitment to scientific integrity, compliance excellence, and continuous improvement. Strong working knowledge of Design Controls, Risk Management, and global regulations (21 CFR 820, ISO 13485, ISO 14971). Experience with software development lifecycles and relevant standards (IEC 62304, IEC 62366) is highly desirable. Demonstrated ability to review DHF documentation, evaluate design change impacts, and drive risk-based decisions. Hands on experience with verification, validation, and claim verification testing. Preferred: 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. Experience supporting or leading Health Authority or Notified Body inspections. Exceptional critical thinking skills and the ability to take calculated, compliant risks. Strong collaboration and communication skills, with a proven ability to influence across matrixed teams. 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 required. 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 $135,000 to $175,000 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

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

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 Principal Quality Partner, Design and Tech Transfer Strategy (Assay). The Design and Tech Transfer Strategy Principal Quality Partner is a global individual contributor within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This individual is responsible 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. The Principal Quality Engineer for Design & Technology Transfer Strategy (Assay) serves as a senior technical leader within the Quality organization, responsible for driving robust, compliant, and efficient design transfer and technology transfer strategies for invitro diagnostic (IVD) assays. This role partners closely with cross functional teams-including R&D, Tech Transfer, Design Quality, and Operations-to ensure that new products and process changes are transferred seamlessly into manufacturing with full adherence to global regulatory expectations. The Principal Quality Partner provides authoritative interpretation of quality and regulatory requirements, deep product and process expertise, and proactive quality oversight to enable successful commercialization, lifecycle changes, and global inspection readiness.vitro diagnostic (IVD) assays. This role partners closely with crossfunctional teams-including R&D, Tech Transfer, Design Quality, and Operations-to ensure that new products and process changes are transferred seamlessly into manufacturing with full adherence to global regulatory expectations. This individual is responsible for fostering a culture of engagement, collaboration, and performance. By integrating technical expertise and data-driven insights, the Principal Quality Partner ensures that Quality systems deliver sustainable business and compliance outcomes. This position will be onsite in Rochester, NY. Serve as the primary Quality partner to the Technology Transfer team, providing strategic guidance and oversight throughout assay design transfer and tech transfer activities. Lead development and execution of comprehensive design transfer and technology transfer quality strategies that ensure compliant, sustainable product realization. Collaborate with Design Quality, Quality Operations, R&D, and Manufacturing teams to ensure alignment on design transfer deliverables, risk management, and process capability expectations. Provide expert interpretation of applicable global regulatory and quality system requirements (e.g., ISO 13485, IVDR, FDA QSR) as they relate to design transfer, process transfer, verification/validation, and manufacturing readiness. Apply deep product and process knowledge to assess transfer risks, guide process understanding, and ensure adequate controls are defined and implemented during scaleup. Support global audit and inspection activities as a subject matter expert and auditee for design transfer, tech transfer, and related quality system elements. Proactively identify quality gaps, systemic risks, and continuous improvement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions.improvement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions. Mentor engineers and contribute to development of organizational capability in design transfer strategy and regulatory compliance. Perform other work-related duties as assigned. Required: Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. Strong product and process knowledge relevant to assay development, verification/validation, and manufacturing workflows. 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. Commitment to scientific integrity, compliance excellence, and continuous improvement. Expert-level knowledge of Design Transfer and Technology Transfer for IVD assays, including process readiness, scaleup, and transfer of product requirements into manufacturing. Deep understanding of IVD regulatory and quality system requirements, such as ISO 13485, IVDR, FDA QSR, risk management (ISO 14971), and design control principles. Strong product and process knowledge relevant to assay development, verification/validation, and manufacturing workflows. Ability to interpret complex regulatory requirements and translate them into actionable design transfer and quality strategies. Demonstrated experience evaluating process capability, process controls, and design outputs to ensure manufacturability and compliance. Preferred: Strong analytical and systemsthinking skills to evaluate endtoend product realization pathways. Ability to anticipate risks in design transfer and proactively implement mitigation strategies. 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. Experience supporting or leading Health Authority or Notified Body inspections. Internal: Tech Transfer, Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, and other 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 required. 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 $135,000 to $175,000 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

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. At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager of Regulatory Affairs. This role will manage and support a team of managers and employees of different levels. You will be responsible for developing and implementing local strategy and leading the day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit. This position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. Interact with US FDA and/or EU Notified Body regulatory personnel (including Corporate International RA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. Responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed. Make judgments about the operational impact of proposed actions, and identify, and interact with appropriate resources to successfully achieve company and regulatory strategy objectives. Reviews/ interprets product-specific regulatory issues that may have a material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment. Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions. Identify and/ or lead process improvement projects to streamline current activities and increase department efficiencies. Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. Coach, mentor junior staff. Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes. Perform other work-related duties as assigned. Required: Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience. 10 years+ of experience in a regulated In Vitro Diagnostics and/ or Biologics Industry. 7+ years of experience developing and executing regulatory strategies for complex projects under product development or post-market changes requiring a US FDA submission (510(k), PMA and BLA or associated supplements and Annual Reports). Review and approval of product labeling and promotional and advertisement brochures and multimedia content. Coordinate and submit Pre-Sub meeting requests and associated regulatory strategic information and direct interaction with FDA product review branch(s). Previous people management experience. Excellent interpersonal, teamwork, and verbal/written communication skills. Good organizational skills and an ability to manage multiple tasks/projects/priorities. The ability to demonstrate model behavior and understand priorities and encourage others to drive for results will be needed. Ability to mentor and coach junior level staff as well as cross-train with peers. This position is not currently eligible for visa sponsorship. Preferred Direct experience with FDA CBER. Experience hosting or supporting Pre-Approval Inspections for either FDA, EU Notified Bodies or both. RAC (Regulatory Affairs Certification). Medical Device and/ or Pharmaceutical Industry experience is highly desirable. CE Mark under IVDD and current IVDR requirements, Canadian Licensing, and Rest of World (ROW) registrations is a plus. Use of Process Excellence (PEx) tools for process improvement initiatives. Internal Partners: Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality/Manufacturing Quality, Regulatory Affairs Managers/Directors, QO International and Regional Regulatory Affairs groups External Partners: Regulators in worldwide markets, for example TUV/BSI, FDA, Health Canada, etc. Third Party Contract Manufacturers and Suppliers. Use of a computer is required. Traditional office workspace or remote home office location. On occasion, may require up to 20% of domestic/international travel. The 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 the facts and circumstances of each case. The salary range for this position is $155,677.15 - $202,380.30 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 the 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-HF1

AML/BSA program evaluation) - Provide structured feedback on AI accuracy in areas such as regulatory standards (FINRA, OCC, FFIEC, FDA, SEC, GDPR, HIPAA), risk frameworks (COSO, ISO 31000), and industry-specific compliance terminology - Collaborate asynchronously with research teams to refine evalua