QMS Specialsit
📍 Belgium (Hybrid) | ⏳ 12‑Month Contract | 🏥 Medical Devices
We'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 Role
As 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 Responsibilities
- Maintain, update, and improve the Quality Management System (QMS) in line with ISO 13485 and regulatory requirements
- Author, review, and update SOPs, work instructions, and quality records
- Support internal and external audits (Notified Body, FDA, MDSAP)
- Drive and support CAPA, deviations, and change control activities
- Partner with stakeholders to ensure consistent QMS application across the business
- Support inspection readiness and audit remediation activities
- Contribute to continuous improvement initiatives across Quality Systems
Required Experience
- Proven experience as a QMS Specialist / Quality Systems Engineer within medical devices
- Strong working knowledge of ISO 13485 and EU MDR (FDA experience a plus)
- Hands‑on experience with QMS documentation, CAPA, change control, and audits
- Comfortable working in a contract / project‑based role
- Able to work independently and manage multiple priorities
- Fluent in English (French or Dutch is beneficial but not essential)
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