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Ortho Clinical Diagnostics

Quality Lead: Design & Tech Transfer Strategy (IVD)

city of rochester, NY

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About this opportunity

Ortho Clinical Diagnostics lists this Quality Lead: Design & Tech Transfer Strategy (IVD) opportunity in city of rochester, New York. Review the employer’s description below for duties, qualifications and application requirements.

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.

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