Sr. Quality Engineer - Medical Device Job at Grove Technical Resources, INC, Los Angeles, CA

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  • Grove Technical Resources, INC
  • Los Angeles, CA

Job Description

Job Description

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.

Job Tags

Contract work,

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