QMS Specialist

📍 Belgium (Hybrid) | ⏳ 12‑Month Contract | 🏥 Medical DevicesWe're supporting a global medical device organisation in Belgium that is seeking an experienced QMS Specialist to join the Quality team on a 12‑month contract. This is a hands‑on role, ideal for someone who thrives in regulated environments and enjoys owning QMS improvement and compliance activities. The RoleAs QMS Specialist, you'll play a key role in maintaining and improving the Quality Management System, ensuring ongoing ISO 13485, EU MDR, and FDA QSR compliance. You'll work cross‑functionally with Quality, Regulatory, Manufacturing, and R&D teams, supporting both operational and project‑based activities. Key ResponsibilitiesMaintain, update, and improve the Quality Management System (QMS) in line with ISO 13485 and regulatory requirementsAuthor, review, and update SOPs, work instructions, and quality recordsSupport internal and external audits (Notified Body, FDA, MDSAP)Drive and support CAPA, deviations, and change control activitiesPartner with stakeholders to ensure consistent QMS application across the businessSupport inspection readiness and audit remediation activitiesContribute to continuous improvement initiatives across Quality SystemsRequired ExperienceProven experience as a QMS Specialist / Quality Systems Engineer within medical devicesStrong working knowledge of ISO 13485 and EU MDR (FDA experience a plus)Hands‑on experience with QMS documentation, CAPA, change control, and auditsComfortable working in a contract / project‑based roleAble to work independently and manage multiple prioritiesFluent in English (French or Dutch is beneficial but not essential)