Principal Quality Engineer

About the role

Enovis is seeking a Principal Quality Engineer to lead quality assurance activities for new product development and sustaining engineering programs. The role ensures that products and processes meet internal quality systems, global regulatory requirements, and industry standards while driving continuous improvement.

Key responsibilities

• Serve as the senior Quality Assurance representative for new product development and sustaining projects.
• Lead design and manufacturing reviews to verify compliance with the Quality Management System and regulatory standards.
• Conduct risk management activities, including development and review of DFMEAs, PFMEAs, and ISO 14971‑based documentation.
• Review and approve design control documents such as design inputs, outputs, verification/validation protocols, and engineering change orders.
• Provide technical leadership during internal, external, customer, and regulatory audits (FDA, ISO 13485, MDSAP).
• Lead complex CAPA investigations, root‑cause analyses, and effectiveness verification.
• Drive Lean, Six Sigma, and quality‑engineering initiatives to improve processes.
• Mentor junior QA engineers and guide cross‑functional project teams.
• Analyze quality metrics, complaint trends, and manufacturing data to identify systemic risks and recommend corrective actions.

Required profile

• Extensive experience in medical device quality assurance and regulatory compliance.
• Proven ability to lead cross‑functional teams and manage complex projects.
• Strong knowledge of FDA, ISO 13485, MDSAP, and ISO 14971 requirements.
• Demonstrated expertise in risk management, design control, and CAPA processes.
• Experience applying Lean and Six Sigma methodologies.

Required skills

• ISO 14971 risk management
• DFMEA and PFMEA development
• FDA regulatory compliance
• ISO 13485 quality management
• MDSAP audit preparation
• Lean and Six Sigma principles
• CAPA investigation and root‑cause analysis
• Design control documentation review