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. Key Responsibilities 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 Qualifications 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 Nice to Have ASQ CQE or similar certification Experience supporting Class II or Class III devices Exposure to FDA inspections or notified body audits #J-18808-Ljbffr EPM Scientific