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o Maintain and improve the Quality Management System (ISO 13485): documentation, process descriptions, internal/external audit preparation.
o Handle complaints and non‑conformities; coordinate actions with MDR requirements and the Belgian authority AFMPS/FAGG. Coordinate compliance and privacy activities: policy upkeep, registers, DPIA follow‑up, data‑breach workflows, awareness. (External partners provide expertise; you ensure internal coordination.)
o Support ethics/industry code obligations (e.g., MDEON) and customer compliance declarations & tenders.
o Administer ERP access rights and authorisations; align with segregation‑of‑duties needs.
o Build and automate management reporting and dashboards (compliance & quality KPIs; operational/financial reports).
o Support risk and performance reviews with the leadership team; drive data‑driven improvements across departments.
* Bachelor's or Master's degree (quality management, business, information management, engineering, law or similar).
* 2-5 years' experience in quality/compliance/risk
* trong digital skills (M365, SharePoint; Power BI/automation a plus). ERP admin/authorisations experience is an asset
* Languages: Dutch & English required; basic French is a plus.
* Competitive salary package and a human‑scale, collaborative environment.
* A newly created role with direct visibility to the Managing Director.
* Real ownership across quality, compliance and IT‑enabled reporting.
* Training and support from external specialists; clear growth trajectory.