Description
Mandated by one of our clients, we are looking for a:
Quality Engineer - GER / ENG / FR
- Advanced technical training in Mechanical Engineering (or equivalent), complemented by training in quality management
- Several years of experience in quality assurance within a production environment (ISO 13485)
- Knowledge of Lean Management is an asset
- Excellent communication skills with internal and external stakeholders
- Very good command of MS Office as well as experience with CAQ and ERP systems
- Languages: German = native language, very good knowledge of English and French
The benefits:
- Join a modern and dynamic company
- A stimulating technical environment, working with high value-added products
- Good conditions
- 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
- Manage change control, deviations, and 8D reports, and lead effective corrective and preventive actions: CAPA
- Plan and support internal and external audits (clients, authorities, and suppliers) and act as the main contact
- Coordinate and lead qualifications and process validations: IQ/OQ/PQ, ensuring their proper implementation
- Be responsible for batch release and ensure that only compliant products proceed in the process
- Actively contribute to the continuous improvement of quality processes using Lean methods
- Participate in the development of the certified quality management system and bring your own ideas, in compliance with ISO 13485 and FDA requirements