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, high‑quality medical devices.

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 nonconforming material and support disposition decisions with engineering and manufacturing teams.
• Investigate product failures, complaints, and trends to identify systemic issues.
• Lead and manage Corrective and Preventive Actions (CAPA) to ensure timely resolution.

Required profile

• Strong technical judgment and deep knowledge of regulated environments for medical devices.
• Experience with design controls, risk management, audit readiness, and continuous improvement.
• Ability to influence cross‑functional teams and drive product safety, quality, and compliance throughout the product lifecycle.

Required skills

• DFMEA and UFMEA development
• ISO 14971 risk‑management standard
• ISO 13485 quality‑management system
• FDA regulatory requirements
• Good Manufacturing Practice (GMP) knowledge
• CAPA management

What we offer

• Opportunity to work on innovative medical‑technology products.
• Collaborative environment focused on continuous improvement.
• Access to global talent and resources.