Quality engineer - ger / eng / fr

Mandated by one of our clients, we are looking for a:

• Higher technical education in Mechanical Engineering (or equivalent), complemented by training in quality management
• Several years of experience in quality assurance in 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

• 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 changes, 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 manage qualifications and process validations: IQ/OQ/PQ, ensuring their proper implementation
• Be responsible for batch release and ensure that only compliant products continue 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