Sr. Quality Engineer – Medical Device

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 :

Qualification :