Quality Compliance Manager

Role Overview

The Quality Compliance Manager oversees all Quality Management System activities, including CAPA management, site quality metrics, document control, training programs, internal and external audits, quality plans, health hazard evaluation, complaint trend analysis, and complaint handling. This role ensures compliance with Quality, Environmental, Health & Safety policies and procedures.

What You Will Do

The Quality Compliance Manager will lead and oversee the Medical Device Complaint Management process, manage the Site Internal Audit Program, and ensure compliance with applicable standards and regulations. They will also define, monitor, and report complaint management KPIs, maintain compliance with ISO 13485 requirements, and support Management Reviews.

Why It Might Be a Fit

The ideal candidate will have strong knowledge of medical device standards and regulations, excellent communication and organizational skills, and experience supervising laboratory teams. They will be able to collaborate effectively with all levels of management across multiple sites and functions.

Requirements

• Minimum of a Master’s degree in a Life Sciences discipline
• Strong knowledge of medical device standards and regulations
• Minimum of 10 years professional experience in medical device or pharmaceutical manufacturing environments
• Strong management and leadership skills
• Excellent communication, organizational, negotiation, and interpersonal skills
• Strong analytical and problem-solving abilities
• Fluent in English and French

Benefits

• Comprehensive benefits package
• Opportunities for professional growth and development
• Collaborative and dynamic work environment