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
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