Senior Quality Engineer – Enabling Technology

About the role

Enovis is seeking a Senior Quality Engineer to lead quality assurance activities for its Enabling Technology portfolio. The role will support new product development and sustaining engineering programs, ensuring compliance with internal and global regulatory requirements.

Key responsibilities

• Act as the senior Quality Assurance representative for new product development and sustaining engineering projects.
• Lead design and manufacturing reviews to verify compliance with the Quality Management System and applicable regulatory standards.
• Conduct risk management activities, including creation and review of DFMEAs, PFMEAs, and risk documentation in line with ISO 14971.
• Review and approve design control documentation such as design inputs, outputs, verification/validation protocols, reports, and engineering changes.
• 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 continuous‑improvement initiatives using Lean, Six Sigma, and quality‑engineering principles.
• Mentor junior QA engineers and guide cross‑functional project teams.
• Analyze quality metrics, complaint trends, non‑conforming material and manufacturing data to identify systemic risks and recommend corrective actions.
• Partner with Engineering, Manufacturing, Regulatory Affairs, Clinical Affairs and Operations to ensure product quality throughout the lifecycle.

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.
• Experience conducting audits, risk assessments and CAPA investigations.
• Demonstrated expertise in Lean and Six Sigma methodologies.

Required skills

• ISO 14971 risk management
• DFMEA and PFMEA analysis
• FDA regulatory compliance
• ISO 13485 quality management system
• MDSAP audit standards
• Lean methodology
• Six Sigma tools
• CAPA investigation techniques
• Design control documentation