Beschreibung

Our client operates in a regulated environment with high quality requirements. This position will allow you to have a concrete impact, with responsibilities, influence, and - Rate % Quality Engineer - Medtech higher technical education (HES), supplemented by training in quality management. Several years of experience in quality assurance in a production environment, ideally in medical devices according to ISO. Good knowledge of Lean Management. Excellent communication skills with internal and external stakeholders. Good command of MS Office as well as experience with CAQ and ERP systems. Languages: French, German (C1), English (B2). We offer: A position with responsibilities with direct influence on quality processes and visible results. A demanding, stimulating, and continuous improvement-oriented environment. An open culture. 6 weeks of vacation. Benefits. Ensure compliance with the highest quality standards and promote a sustainable quality culture in a regulated environment (GxP, ISO, FDA 21 CFR Part 820). Handle non-conformities and 8D reports, and drive effective corrective and preventive actions (CAPA). Plan and support internal and external audits (clients, authorities, and suppliers) as a reference person. Coordinate and drive validations and process qualifications (IQ/OQ/PQ), and ensure their implementation. Ensure the release of batches and ensure that only compliant products continue the process. Actively contribute to the continuous improvement of quality processes through Lean methods and an efficiency and impact-oriented approach. Participate in the development of the certified quality management system and contribute your ideas in accordance with ISO and FDA requirements. jid03680ebaen jit0624aen jpiy26aen