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.