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RXinsider LTD.

Global Design Transfer Quality Lead for IVD Assays

city of rochester, NY

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Job description

QuidelOrtho, headquartered in Rochester, NY, seeks a Quality Lead for Design and Tech Transfer Strategy (Assay) to drive robust transfer strategies aligned with ISO 13485, IVDR, and FDA QSR. This senior individual contributor partners with R&D, Tech Transfer, Design Quality, and Operations to ensure seamless transfer into manufacturing while maintaining regulatory compliance.

The role emphasizes leadership, data-driven decision making, and continuous improvement in a global quality environment,

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