Senior Quality Engineer

We're Hiring | Senior Quality Engineer – New Product Development (NPD) | Medical Devices

Are you passionate about building quality into innovative medical devices from concept to commercialization We're looking for an experienced Senior Quality Engineer – New Product Development (NPD) to join our growing team and play a critical role in delivering safe, effective, and compliant medical devices

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About the Role

As a Senior Quality Engineer – NPD, you will collaborate closely with Design Engineering, Test Engineering, Advanced Operations, Manufacturing, Regulatory Affairs, and Supplier Quality teams to ensure quality excellence throughout the product development lifecycle.

You will provide technical leadership in:

✅ Design Assurance

✅ Risk Management (ISO 14971)

✅ Design Controls (FDA QSR/QMSR & ISO 13485)

✅ Process & Design Validation

✅ Usability Engineering (IEC 62366-1)

✅ Manufacturing & Supplier Quality

Key Responsibilities

Lead and support Design Assurance activities for new product development.

Ensure compliance with FDA, ISO 13485, and applicable regulatory requirements.

Develop and maintain Design History Files (DHF) and Risk Management Files.

Facilitate dFMEA, pFMEA, uFMEA, Hazard Analysis, and Functional Analysis.

Support Design Verification, Validation, Process Validation, Software Validation, and Sterilization Validation activities.

Partner with Manufacturing and Advanced Operations during design transfer.

Support supplier qualification, PPAP, supplier validations, and continuous quality improvement initiatives.

What We're Looking For

✔ Bachelor's degree in Biomedical, Mechanical, Electrical, Manufacturing Engineering, or related discipline.

✔ 5–10 years of Quality Engineering, Design Assurance, or Product Development experience in the medical device industry.✔

Strong knowledge of Design Controls, Risk Management, and regulated product development.

✔ Experience supporting New Product Development (NPD).

✔ Excellent analytical, communication, and cross-functional collaboration skills.

✔ Ability to manage multiple priorities and drive quality-focused outcomes independently.

Who You Are

A proactive, self-driven professional who takes ownership.

A collaborative team player who builds strong stakeholder relationships.

A data-driven problem solver focused on continuous improvement.

If you're ready to make an impact by developing innovative medical devices that improve patient lives, we'd love to hear from you!

Interested Apply now or share your profile

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