Location: Kontich, Belgium
Position: Quality System & Governance Senior Specialist
Industry: Medical Devices / Pharmaceuticals
Type: Permanent
A growing international MedTech and pharmaceutical company is looking to strengthen its Quality team with the addition of a Quality System & Governance Senior Specialist.
This is a brilliant opportunity for an experienced Quality professional who enjoys owning and improving Quality Management Systems within a highly regulated environment, while working closely with cross-functional teams across QA, Regulatory, and product development.
Key Responsibilities:
• Own and maintain the company-wide Quality Management System (QMS)
• Lead Management Review activities and oversee quality KPIs and governance metrics
• Manage the internal audit programme and support audit readiness activities
• Drive CAPA follow-up, SOP governance, document control, and continuous improvement initiatives
• Oversee QA training governance and training matrix management
• Support alignment across Quality, Regulatory, Design & Development, and Lifecycle Management teams
• Ensure compliance with ISO 13485, MDR, and applicable GxP requirements
Requirements:
• 5+ years of experience within Medical Device Quality Assurance
• Strong experience with QMS governance, audits, CAPA, SOPs, and compliance activities
• Strong knowledge of ISO 13485 and MDR
• Experience within regulated Medical Device and/or Pharmaceutical environments
• Internal auditing experience is highly desirable
• Strong communication and stakeholder management skills
• Fluent English required, additional European languages are beneficial
What’s on offer:
• Opportunity to join a growing international MedTech business
• Strong long-term progression opportunities
• High-visibility role within the Quality function
• Collaborative and innovative working environment
• Competitive salary and package
If you would be interested in hearing more, please apply directly or reach out to me for a confidential discussion.