Senior Quality Engineer - Drug-Device Combo, FDA Readiness

Pave Talent is recruiting a Quality Engineer for a medical technology client in the Washington, DC region (Gaithersburg, MD). The role focuses on quality activities for a drug-device combination product approaching FDA clearance.

You will own design controls, risk management, CAPA, and validation on real equipment and processes. The ideal candidate has hands-on experience in FDA-regulated manufacturing, ISO 13485, and 21 CFR Part 820, with a comfort level working in a small company where the