Senior Quality Engineer – New Product Development (NPD)

About the role

We are seeking a Senior Quality Engineer to lead quality initiatives for new medical device products from concept through commercialization. You will work closely with design, test, manufacturing, regulatory, and supplier teams to embed quality throughout the development lifecycle.

Key responsibilities

• Lead Design Assurance activities and ensure compliance with FDA QSR, ISO 13485, and other applicable regulations.
• 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.
• Partner with Manufacturing and Advanced Operations during design transfer.
• Drive supplier qualification, PPAP, supplier validations, and continuous quality improvement.

Required profile

• Bachelor’s degree in Biomedical, Mechanical, Electrical, Manufacturing Engineering or a related field.
• 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.
• Proven ability to manage multiple priorities and deliver quality‑focused outcomes independently.

Required skills

• ISO 14971 (Risk Management)
• ISO 13485 (Quality Management System)
• FDA QSR (Design Controls)
• Design History Files (DHF) management
• FMEA (dFMEA, pFMEA, uFMEA)
• Hazard and Functional Analysis
• Design Verification & Validation
• Process, Software, and Sterilization Validation
• Usability Engineering (IEC 62366‑1)
• PPAP and Supplier Qualification