Quality System & MDR Certification Coordinator
On-siteGroßostheim, Bavaria, Germany
Großostheim, Bavaria, GermanyOn-siteFull TimeSmall
Full TimeSmall
Job Summary
Manage the Quality Management System, serving as the single point of control for documentation and end-to-end traceability. Develop and execute the MDR certification timeline, coordinate gap analysis, and track closure of findings with the certification body. Assign owners and due dates for the CAPA plan, maintain a progress dashboard, and escalate delays to leadership. Create monthly dashboards for four workstreams and manage audit logistics for internal and MDR audits. Execute local Post-Market Surveillance documentation and handle purchasing logistics for quality projects.
Required Qualifications
- Engineering, science, or business administration degree
- 3–5 years in medical devices or a regulated industry (pharmaceutical or automotive experience acceptable), in coordination, quality, or PMO roles
- Practical knowledge of ISO 13485
- Familiarity with Regulation (EU) 2017/745 (MDR)
- Native German or C1+ German
- B2 English or higher
- Project management tools (MS Project, Planner, or equivalent)
- Advanced Excel skills
- Impeccable organization and strong follow-through without full hierarchical authority over all areas
- High tolerance for detailed documentation
Desired Qualifications
- Previous experience participating in MDR certification processes
- ISO 13485 audits
- Spanish
- Experience tracking systems they have built and maintained for more than one year
- Experience ensuring that others meet deadlines
- Direct experience with certification processes or regulatory audits
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