Medical Device Quality Assurance Engineer

About the role

Enovis is seeking a Medical Device Quality Assurance Engineer to join its Quality Team in Austin, Texas. The role supports manufacturing operations, ensures compliance with regulatory standards, and drives continuous improvement in product quality.

Key responsibilities

• Evaluate non‑conforming material and disposition decisions through cross‑functional engineering review.
• Analyze production data and reports to identify trends and drive corrective actions.
• Develop, update, and author quality standards, procedures, and work instructions.
• Lead root‑cause investigations, corrective and preventive actions, and material review board activities.
• Perform process and equipment validations (IQ/OQ/PQ) and support manufacturing transfers.

Required profile

• Bachelor’s degree in Science or Engineering with 3‑5 years of relevant experience, or 10‑12 years directly in a quality role.
• Experience in regulated environments such as medical devices, aeronautics, or automotive.
• Knowledge of ISO 13485, GMP, FDA, and CMDR compliance requirements.
• Ability to lift 50 lb, bend, twist, and work overhead.

Required skills

• SolidWorks and SolidWorks ePDM.
• Oracle R12 and Agile PLM.
• Microsoft Office Suite (Excel, Word, PowerPoint).
• Understanding of manufacturing processes: metrology, precision machining, grinding, cleaning, sterilization.

What we offer

• Medical, dental, and vision insurance.
• 401(k) plan and income protection.
• Paid vacation, sick leave, and holidays.
• Legal services and discounted insurance rates.