Global Quality Lead, Assay Requirements & Specs

QuidelOrtho in the United States is seeking a Quality Lead, Requirements and Specifications Management (Assay) to drive end-to-end quality across a portfolio of assay-based medical devices. This global role partners with R&D, Systems Engineering, Regulatory, Manufacturing, and Product Management to ensure robust design inputs and compliant development. The position requires a Bachelor's in Life Sciences or engineering, 7+ years in quality/compliance, and deep knowledge of ISO 13485, FDA 21 CFR