Supplier Quality Engineer – Medical Device Industry

Supplier Quality Engineer – Medical Device Industry

📍 Camarillo CA – United States

Must be authorized to work. No relocation US Citizen or Green Card holder

Join a growing medical device organization focused on quality, compliance, and continuous improvement. This role will play a key part in ensuring externally sourced materials, components, and services meet FDA, ISO, and internal quality standards.

🎯 What We’re Looking For

• 5 years of Quality experience within the medical device industry

• Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485, ISO 14971, and supplier quality systems

• Experience conducting supplier audits independently

• Background managing SCARs, CAPAs, supplier performance metrics, and audit readiness

• Bachelor’s degree in Engineering, Quality, or related technical field

• ASQ Auditor or ISO 13485 Lead Auditor certification preferred

🔹 Ideal Background

Experience supporting medical device manufacturing, supplier oversight, validation activities (IQ/OQ/PQ), sterilization suppliers, and risk management processes.

🔑 What You’ll Do

• Lead supplier qualification and onboarding activities

• Conduct supplier audits (remote and on-site)

• Manage supplier performance metrics, SCARs, CAPAs, and nonconformances

• Support validation activities, change controls, and risk assessments

• Partner cross-functionally with Supply Chain, Manufacturing, Engineering, R&D, and Regulatory teams

• Drive continuous improvement initiatives with suppliers

Work Authorization:

This role requires current authorization to work in the United States. We are unable to provide visa sponsorship now or in the future

The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process,

Apply, and please feel free to reach out.