Quality Assurance Engineer (Medical Technology)

About the role

Enovis is seeking a highly skilled Quality Assurance Engineer to lead and support QA activities across new product development and sustaining engineering programs. You will ensure compliance with internal quality systems, industry standards, and global regulatory requirements while contributing to the delivery of safe, effective medical technologies.

Key responsibilities

• Serve as the QA representative on new product development and sustaining engineering projects.
• Participate in design and manufacturing reviews to verify compliance with quality system requirements.
• Develop and maintain DFMEA/UFMEA documentation and lead risk‑management discussions aligned with ISO 14971.
• Review and approve design control documentation, including specifications, verification/validation records, and design outputs.
• Act as subject‑matter expert for design quality during internal and external audits (ISO, FDA, GMP).
• Author, review, and maintain quality system procedures, work instructions, and controlled documentation.
• Conduct internal audits across quality‑system processes and supporting business functions.
• Evaluate non‑conforming material and support disposition decisions with engineering and manufacturing teams.
• Investigate trends in product failures, complaints, and non‑conforming material to identify systemic issues.
• Lead and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution.

Required profile

• Strong technical judgment and deep knowledge of regulated medical‑device environments.
• Proven ability to influence cross‑functional teams and drive continuous improvement.
• Experience with design controls, risk management, audit readiness, and quality‑system maintenance.
• Excellent analytical skills and attention to detail.

Required skills

• DFMEA and UFMEA development.
• Risk‑management standards (ISO 14971).
• Quality‑system standards (ISO 13485, FDA regulations, GMP).
• CAPA management.
• Internal audit execution.
• Design control documentation review.