Vice President of Quality – Medical Device

About the role

We are seeking a Vice President of Quality to lead the quality function for a fast‑growing, regulated medical‑technology company in Canada. The role will define and scale a world‑class Quality Management System, ensuring product safety, compliance and reliability across hardware, software and system‑level solutions.

Key responsibilities

• Own the ISO 13485 certification roadmap, from gap assessment to audit completion and ongoing surveillance.
• Design and embed a PLM‑integrated Quality Management System that links requirements, design, validation and risk artifacts.
• Establish and continuously improve core QMS processes such as document control, CAPA, internal audits, complaint handling, risk management and post‑market surveillance.
• Define quality standards for hardware, software and electromechanical systems in line with ISO 14971, IEC 62304 and FDA 21 CFR Part 820.
• Build and lead supplier and manufacturing quality programs, including audits, qualification, incoming inspection and Six‑Sigma improvement initiatives.
• Act as the escalation point for customer‑facing quality issues, driving root‑cause analysis and corrective actions.
• Recruit, mentor and develop a high‑performing quality organization that promotes early issue detection and cross‑functional ownership.

Required profile

• 10+ years of progressive quality leadership experience in the medical‑device industry.
• Hands‑on responsibility for multiple ISO 13485 certifications and proven audit readiness.
• Deep knowledge of regulated environments and enterprise‑scale product development.

Required skills

• ISO 13485 certification and QMS design.
• ISO 14971, IEC 62304 and FDA 21 CFR Part 820 compliance.
• PLM integration and traceability.
• CAPA, risk management and post‑market surveillance processes.
• Supplier quality management and Six‑Sigma methodologies.
• Document control and internal audit execution.