QA System & Document Control Engineer

Main Tasks & Responsibilities*** Maintain Integrated Management Systems1. Design, implement, and continuously improve ISO-compliant management systems, ensuring cross-standard synergy and operational efficiency. 2. Plan and conduct internal audits (system, process, product) annually, deliver audit reports, and drive CAPA (Corrective and Preventive Actions) closure. 3. Manage external audits (certification bodies, customer audits), lead non-conformance resolution, and maintain valid certifications. 4. Monitor updates to ISO, RBA, and regional regulations, and adapt policies/procedures proactively. *** Document Control & Lifecycle Management5. Establish and enforce document control procedures, covering creation, review, approval, distribution, revision, obsolescence, and archiving. 6. Ensure traceability, version control, and compliance of technical documents (e.g., medical device technical files) and quality records. 7. Administer electronic document management systems (e.g., SharePoint, Documentum), optimizing access controls and audit trails. *** RBA Compliance RBA 8. Implement RBA Code of Conduct across operations and supply chain. 9. Lead RBA audit preparation, execution and corrective action follow-up. 10. Deliver RBA training programs to enhance organizational awareness. *** ESG & CSRD Integration ESG 11. Support ESG strategy development and KPIs for sustainability. 12. Track CSRD requirements and draft ESG disclosures. 13. Collaborate on sustainability initiatives (e.g., circular economy). 14. Other tasks assigned by line manager.