Job Description
- Maintain and improve the Quality Management System (ISO 13485): documentation, process descriptions, internal/external audit preparation.
- 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.)
- Support ethics/industry code obligations (e.g., MDEON) and customer compliance declarations & tenders.
- Administer ERP access rights and authorisations; align with segregation‑of‑duties needs.
- Build and automate management reporting and dashboards (compliance & quality KPIs; operational/financial reports).
- Support risk and performance reviews with ...
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