Onsite Senior Quality Engineer – Medical Devices

Real Staffing; Menlo Park (CA); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Specialist Staffing Group is seeking a Senior Quality Engineer in Menlo Park, CA to join a fast-growing medical device company. You will lead quality activities across product development, verification and validation, risk management, and manufacturing readiness, collaborating with R&D, Operations, Clinical, and Regulatory teams.

The role requires 8+ years of medical device quality engineering, strong knowledge of ISO 14971, ISO 13485, and FDA 21 CFR Part 820, with hands-on experience in design

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or related field.
• 8+ years medical device quality engineering with Bachelor's or 6+ years with Master's.
• Experience with design controls, DHF/DMR, and ISO 14971 risk management.

Responsabilités

• Serve as QA representative on NPD teams with design controls and DHF/DMR deliverables.
• Lead risk management activities per ISO 14971, including FMEAs and risk controls.
• Develop/execute V&V strategies with requirements traceability and method validation.
• Support design transfer and manufacturing readiness, including inspection plans and DMR inputs.
• Review/approve validation protocols and reports (IQ/OQ/PQ, sterilization, packaging).
• Drive biocompatibility planning per ISO 10993 and coordinate with labs.
• Lead investigations of complaints, deviations, CAPAs, and supplier quality issues.
• Assess ECOs for quality impact and ensure verification/validation adequacy.
• Support supplier qualification, audits, and supplier performance monitoring.

Connaissances

Design controls

DHF/DMR management

Risk management (ISO 14971)

FDA 21 CFR 820

ISO 13485

CAPA / NCR / NCMR

Change control

Cross-functional collaboration

Formation

Bachelor's degree in Engineering / Biomedical Engineering / Life Sciences

Master's degree (preferred)

Description du poste

Specialist Staffing Group is seeking a Senior Quality Engineer in Menlo Park, CA to join a fast-growing medical device company. You will lead quality activities across product development, verification and validation, risk management, and manufacturing readiness, collaborating with R&D, Operations, Clinical, and Regulatory teams.

The role requires 8+ years of medical device quality engineering, strong knowledge of ISO 14971, ISO 13485, and FDA 21 CFR Part 820, with hands-on experience in design