About this role
QA/RA Lead Amsterdam Hartwig Medical Foundation Few roles offer the opportunity to combine quality, innovation and societal impact at this level. For Hartwig Medical Foundation, we are looking for an experienced Quality Assurance Lead who wants to make a real impact within an organisation at the forefront of genomic diagnostics. In this role, you will contribute not only to an outstanding quality system but also to better treatment decisions for thousands of cancer patients. You will have the opportunity to shape the quality strategy within an international organisation where software, diagnostic laboratories and medical regulations come together. Here, quality is regarded not as an obligation but as an essential part of innovation. Functie omschrijving - Further develop the integrated Quality Management System. - Ensure compliance with ISO 13485, ISO 17025 and ISO 27001, and support the implementation of ISO 15189. - Lead internal audits, external audits and accreditation processes. - Develop the Regulatory Affairs strategy for MDR, IVDR and SaMD. - Lead Post-Market Surveillance, Vigilance and Technical Documentation activities. - Coach the experienced Quality & Regulatory Affairs team (3-6 fte). - Advise senior management on quality, risk, compliance and regulatory matters. - Budget and KPI responsible. - Create and foster a pragmatic quality culture. Bedrijfsprofiel Hartwig Medical Foundation is a leading Dutch organisation in genomic diagnostics. Through advanced DNA analysis, Hartwig supports physicians in making better treatment decisions for people with cancer. The combination of research, software development, bioinformatics and diagnostic laboratories makes this a unique opportunity. Please note : In accordance with our client's request, Hartwig Medical Foundation will only consider applications submitted through MY Recruitment. Profiel kandidaat You can easily switch between the boardroom and day-to-day oper...