Staff Design Quality Assurance Engineer (Hybrid - San Diego, CA)

Summary

Lead Design Quality Assurance and Quality Engineering activities across the full product development lifecycle for FDA Class II and III medical devices. Integrate design controls, system-level risk management, and verification/validation into a cohesive framework with clear traceability. Partner cross-functionally with R&D, Systems Engineering, Hardware/Software Engineering, Manufacturing, Regulatory Affairs, and external stakeholders to embed quality early in development. Drive continuous improvement initiatives, standardize processes, and ensure compliance with FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and IEC standards.