The Role

As we continue to grow as one QuidelOrtho we are seeking a Quality Lead, Design and Tech Transfer Strategy (Assay). The Design and Tech Transfer Strategy Quality Lead 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 Quality Lead 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 Quality Lead 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 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.

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 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.‑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, 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.

Preferred:

• 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.

• 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.