Job Title: Sr. Quality Engineer – Medical Device
Location: Northridge, CA (Fully Onsite)
Type: 12-Month W2 Contract
Summary:
We’re seeking an experienced Senior Quality Engineer to support the full product development lifecycle for implantable and electro-mechanical medical devices. The ideal candidate will have strong expertise in Design Controls, Risk Management (FMEA, Hazard Analysis), and Validation (TMV, IQ/OQ/PQ), ensuring compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and EU-MDR standards.
Key Skills:
• Design Control & Regulatory Compliance (ISO 13485, 21 CFR 820, EU-MDR)
• Risk Management (FMEA, Hazard Analysis)
• Electro-mechanical
• Design Verification & Validation Testing
• Process Validation (TMV, IQ/OQ/PQ)
• Supplier Qualification & Design Transfer
• Problem Solving / CAPA / Continuous Improvement.
Preferred:
• Experience with IEC 62304 and IEC 60601-1
• ASQ Certification (Quality/Reliability)
• Strong communication & documentation skills.
Qualification:
• Bachelor’s in Engineering/Science with 5+ years, or Master’s with 3+ years in Quality/Engineering.