Quality Engineer - MedTech - ALL / ANG / FR

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

Higher technical education in Mechanics (or equivalent), completed by training in quality management
Several years of experience in quality assurance in a production environment (ISO 13485)
Knowledge of Lean Management = an asset
Excellent communication skills with internal and external interlocutors
Very good mastery of MS Office as well as experience with CAQ and ERP systems
Languages: German = native language, very good knowledge of English and French

Advantages:

Join a modern and dynamic company
A stimulating technical environment, in contact 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
Take charge of change management, deviations as well as 8D reports, and pilot effective corrective and preventive measures: CAPA
Plan and support internal and external audits (customers, authorities and suppliers) and act as the main interlocutor
Coordinate and pilot qualifications as well as process validations: IQ/OQ/PQ, and ensure their proper implementation
Be in charge of 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

Automatically translated from the original.

Posted 7 weeks ago

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