Beschreibung
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