Senior Design Quality Engineer
Role: Senior Design Quality Engineer
Salary: $135k - $155k
Location: Irvine, CA (On-site)
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
Benefits:
- Competitive compensation
- Bonus
- Medical, vision, dental
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