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About the Role
As a global individual contributor within QuidelOrtho's Global Quality & Compliance organization, this role ensures the design, implementation, and continuous improvement of Quality systems, processes, and programs. The Quality Lead Engineer serves as a senior technical leader responsible for driving robust, compliant, and efficient design transfer and technology transfer strategies for in vitro diagnostic (IVD) assays, partnering with cross-functional teams to ensure seamless product commercialization and lifecycle changes.
Responsibilities
- 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 scale-up.
- 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.
- Mentor engineers and contribute to development of organizational capability in design transfer strategy and regulatory compliance.
- Perform other work-related duties as assigned.
Requirements
- 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, scale-up, 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.
- Strong analytical and systems-thinking skills to evaluate end-to-end product realization pathways.
- Ability to anticipate risks in design transfer and proactively implement mitigation strategies.
- 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.
Skills
- Design Transfer
- Technology Transfer
- IVD Assays
- Quality Systems
- Regulatory Compliance
- ISO 13485
- IVDR
- FDA QSR
- Risk Management
- ISO 14971
- Design Control
- Process Capability
- Process Controls
- Manufacturing Workflows
- Collaboration
- Communication
- Analytical Skills
- Problem-Solving
- Data-Driven Decision-Making
- Continuous Improvement
- Systems Thinking
- Lean Six Sigma
- PMP
Location
- Rochester, NY
Work Type
- Onsite
- Full-time
Experience Level
- 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
- Senior technical leader
Education Level
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline
- Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline (Preferred)
Salary/Compensations
- $135,000 to $175,000 and is bonus eligible
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(k) plan
- Employee assistance program
- Employee Stock Purchase Plan
- Paid time off (including sick time)
- Paid Holidays
About the Company
- 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.
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 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 recruiting@quidelortho.com.