Quality Lead Design Transfer & Tech Transfer Strategy

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. With over 6,000 employees and operations in more than 130 countries, we provide fast, accurate, and consistent testing from home to hospital, lab to clinic. Our culture prioritizes team member happiness, inspiration, and engagement, fostering meaningful connections to drive both employee well-being and business success.

About the role

The Design and Tech Transfer Strategy Quality Lead is a global individual contributor within QuidelOrtho’s Global Quality & Compliance (GQ&C) organization. This role ensures the design, implementation, and continuous improvement of Quality systems, processes, and programs that support QuidelOrtho’s right to operate, business agility, innovation, and growth. As a senior technical leader, the Quality Lead Engineer drives robust, compliant, and efficient design transfer and technology transfer strategies for in vitro diagnostic (IVD) assays.

The role partners closely with cross-functional teams—including R&D, Tech Transfer, Design Quality, and Operations—to ensure seamless transfer of new products and process changes into manufacturing, fully adhering 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. This position is onsite in Rochester, NY.

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 to ensure compliant, sustainable product realization.
• Collaborate with Design Quality, Quality Operations, R&D, and Manufacturing teams to align 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 the 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.
• 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.
• 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.

Preferred Qualifications

• 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.
• 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.

Key Interactions

• 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.

Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse setting. The role may include occasional travel for site visits, leadership meetings, or regulatory support. No strenuous physical activity is required.

Culture

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:

• 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.

Pay

Salary range for this position is $135,000 to $175,000 and is bonus eligible. The range takes into account factors such as education, experience, knowledge, skills, geography, and abilities of the candidate, as well as internal equity and market alignment.

Benefits

• Comprehensive medical, dental, and vision insurance.
• Life and disability insurance.
• 401(k) plan.
• Employee assistance program.
• Employee Stock Purchase Plan.
• Paid time off (including sick time) and paid holidays.