Principal Quality Engineer

Lead quality engineering efforts for a medical device program in Campbell, CA, focusing on establishing quality plans, regulatory compliance, and lifecycle quality systems. Oversee sterilization and biocompatibility activities, mentor junior staff or contract labs, and collaborate with cross-functional teams on pilot production and supplier quality. Responsible for designing controls within the design control system, executing validation studies for sterilization, and generating BEPs while ensuring compliance with ISO 13485, FDA 21 CFR Part 820, ISO 14971 risk management, and related guidelines. Maintain rigorous documentation, support regulatory submissions/audits, and drive continuous improvement through CAPAs, NCMRs, SCARs, and supplier performance management. Strong emphasis on technical liaison with laboratories and manufacturing sites, and on ensuring product quality from development through distribution.