Senior Design Quality Engineer

EPM is partnered with a growing medical device company in Orange County that's continuing to build out its Quality function and looking to bring in a Senior Design Quality Engineer. This is a high-impact role supporting product development end-to-end, working closely with R&D and cross-functional teams to ensure quality and compliance are built into products from concept through commercialization.

• Support product development activities in compliance with FDA (21 CFR Part 820), QMSR, and ISO 13485 requirements
• Own and support Design Controls throughout the lifecycle (design inputs/outputs, DHF, design reviews)
• Review and approve verification & validation protocols, reports, and traceability documentation
• Lead and support risk management activities (ISO 14971), including hazard analysis and risk assessments
• Partner cross-functionally with R&D, RA, Manufacturing, and Operations during development and design transfer

• Bachelor's degree in Engineering, Biomedical Engineering, or related technical field
• 3+ years of Design Quality / Quality Engineering experience in medical devices
• Strong working knowledge of FDA 21 CFR Part 820 and ISO 13485
• Hands-on experience with Design Controls, V&V, and risk management (ISO 14971)
• Experience supporting product development in a regulated environment
• Exposure to CAPA, audits, and cross-functional collaboration

• ASQ CQE or similar certification
• Experience supporting Class II or Class III devices
• Exposure to FDA inspections or notified body audits