Senior Supplier Quality Engineer – Medical Devices

Katalyst CRO is seeking a hands-on Supplier Quality Engineer to own supplier qualification, approval, and lifecycle management for medical device components. You will manage ASLs, conduct supplier audits, and drive PPAP submissions in a regulated setting. The role requires IQ/OQ/PQ process validation understanding, risk-based decision making per ISO 14971, and collaboration with Procurement, Engineering, Manufacturing, QA, and Regulatory Affairs to ensure compliant sourcing across multiple