Quality Lead Design Transfer & Tech Transfer Strategy

About this role

The Opportunity   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

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.

The 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.‑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.

The Individual

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,

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