Location: Kontich, BelgiumPosition: Quality System & Governance Senior SpecialistIndustry: Medical Devices / PharmaceuticalsType: PermanentA 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 requirementsRequirements:
- 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 beneficialWhat'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 packageIf you would be interested in hearing more, please apply directly or reach out to me for a confidential discussion.