Quality System Specialist

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.