Quality Lead: Design & Tech Transfer Strategy (IVD)

Ortho Clinical Diagnostics; City of Rochester (NY); On-site; USD 135,000 - 175,000; Full time

Job summary

QuidelOrtho seeks a Quality Lead, Design and Tech Transfer Strategy (Assay) to drive robust design transfer and technology transfer for in vitro diagnostic assays. You will partner with R&D, Tech Transfer, Design Quality, and Operations to ensure seamless manufacturing transfer with full regulatory compliance.

The role requires a Bachelor's in Life Sciences or Engineering and 10+ years in Quality/Compliance within medical devices or IVD, with ISO 13485, IVDR, and FDA QSR experience.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related technical discipline.
• 10+ years in Quality, Compliance, or related fields within Medical Device/IVD/Biopharma.
• Strong knowledge of ISO 13485, IVDR, FDA 21 CFR 820.
• Experience in assay development, verification/validation, and manufacturing workflows.
• Excellent collaboration, influence, and communication across functions.
• Analytical and problem-solving skills with data-driven decisions.
• Expert knowledge of Design Transfer and Technology Transfer for IVD assays.

Responsibilities

• Serve as primary Quality partner to Technology Transfer team for assay design and tech transfer.
• Lead design transfer and technology transfer quality strategies for compliant product realization.
• Collaborate with Design Quality, Quality Operations, R&D, and Manufacturing on transfer deliverables.
• Interpret global regulatory requirements (ISO 13485, IVDR, FDA QSR) for transfer and manufacturing readiness.
• Assess transfer risks, guide process understanding, implement controls during scale-up.
• Support audits/inspections as SME and auditee for transfer and related QMS elements.
• Identify quality gaps and lead cross-functional teams to implement solutions.

Skills

Collaboration

Influence

Communication

Analytical thinking

Problem solving

Education

Bachelor's degree in Life Sciences or Engineering

Job description

QuidelOrtho seeks a Quality Lead, Design and Tech Transfer Strategy (Assay) to drive robust design transfer and technology transfer for in vitro diagnostic assays. You will partner with R&D, Tech Transfer, Design Quality, and Operations to ensure seamless manufacturing transfer with full regulatory compliance.

The role requires a Bachelor's in Life Sciences or Engineering and 10+ years in Quality/Compliance within medical devices or IVD, with ISO 13485, IVDR, and FDA QSR experience.