Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a general healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We are looking for a Quality Assurance Specialist for ensuring the quality of the products of the Diagnostic Grifols division, dedicated to the design and manufacture of in vitro diagnostic systems for blood typing.
What your main responsibilities will be
• Participate in Quality Assurance activities across the entire lifecycle of diagnostic products, including design and development, industrialization, manufacturing, release, post‑market activities,
and end‑of‑life management in accordance with ISO 13485, Regulation (EU) 2017/746 for IVDR, and FDA Quality Management System Regulation (QMSR).
• Participate in the quality management of intercompany processes ensuring alignment with applicable Quality System requirements.
• Monitor intercompany quality indicators and agreed KPIs, ensuring their follow-up and integration into Quality Committees and PMSR-related activities, where applicable.
• Collaborate in investigations, NCs, Complaints, CCs APAs related to intercompany activities, ensuring appropriate documentation, traceability and follow-up according to applicable procedures.
• Ensure the quality and compliance of raw materials, intermediate products and finished instruments, including spare parts, through active involvement in qualification, requalification and deviation management activities.