Our client operates in a regulated environment with high quality demands. This position will allow you to have a tangible impact, with responsibilities, influence and visible results.
Permanent contract - 80-100% rate
Quality Engineer - Medtech 80-100%
Higher technical education (HF/HES), complemented by a specialisation in quality management Several years of experience in quality assurance in a production environment, ideally in medical devices according to ISO 13485 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 and direct influence on quality processes and visible results A demanding, stimulating environment focused on continuous improvement An open culture 6 weeks of holiday Attractive employee benefits Ensure compliance with the highest quality standards and promote a sustainable quality culture in a regulated environment (GxP, ISO 13485, FDA 21 CFR Part 820) Handle changes, deviations and 8D reports, and lead effective corrective and preventive actions (CAPA) Plan and support internal and external audits (clients, authorities and suppliers) as the point of contact Coordinate and lead process qualifications and validations (IQ/OQ/PQ), and ensure their implementation Ensure batch release 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 13485 and FDA requirements
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