Quality Compliance Manager

About the role

The Quality Compliance Manager oversees all Quality Management System activities, ensuring compliance with quality, environmental, health and safety policies and regulatory requirements. This role drives complaint handling, audit programs, CAPA processes and continuous improvement across the site.

Key responsibilities

• Lead the medical device complaint management process, including evaluation, investigation, root cause analysis and KPI reporting.
• Manage the site internal audit program, develop the annual audit schedule and ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and other regulations.
• Oversee CAPA activities, facilitate review board meetings and monitor performance metrics.
• Maintain the document control system within the PLM environment and manage the Learning Management System for training compliance.
• Lead, coach and develop a multidisciplinary team of quality engineers and technicians, allocating resources and setting performance objectives.

Required profile

• Master’s degree in a Life Sciences discipline.
• Minimum 10 years of experience in medical device or pharmaceutical manufacturing.
• Strong management and leadership skills with experience supervising laboratory teams.
• Fluent in English and French with excellent communication and interpersonal abilities.

Required skills

• In‑depth knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, 93/42/EEC and other global medical device regulations.
• Experience with CAPA management, internal and external audits, and complaint handling processes.
• Proficiency in document control systems within a PLM environment.
• Ability to manage learning management systems (LMS) and training compliance.