Quality Engineer

We are seeking a Quality Engineer to join the Operations Quality team, reporting to the Associate Director of Operations Quality. This role focuses on the design and development of clinical and commercial Class II medical devices and will work closely with Product Development, Quality Control, Regulatory Affairs, and Manufacturing.

Key Responsibilities:

• Support design controls, risk management, and Design History File (DHF) creation/maintenance.

• Review and approve design documentation, verification/validation protocols, and risk analyses (dFMEA, uFMEA, pFMEA).

• Assess product designs for manufacturability, reliability, biocompatibility, sterility, and compliance.

• Lead or support investigations, root cause analyses, change control, and complaint resolution.

• Contribute to vendor management, audits, and product release documentation.

Qualifications:

• BS in Engineering with 5+ years, or MS with 3+ years of relevant experience.

• 2–5 years in a regulated medical device environment; combination product experience preferred.

• Strong knowledge of ISO 13485, ISO 14971, 21 CFR 820, and cGxP.

• Experience with DHFs, product risk management, verification/validation, and lifecycle management.

• Excellent technical writing, statistical, and cross-functional teamwork skills.