Responsable assurance qualité h/f

Genius Talent est un cabinet de recrutement créé par des ingénieurs passionnés d'intelligence artificielle et des chasseurs de tête expérimentés spécialisés dans la recherche de talent. Une méthode agile et performante pour vos recrutements et un accompagnement personnalisé pour les talents. CV en anglais exigé
Key Duties and Responsibilities :
Product Quality Management :
- Manage product quality control
- Releasing finished products
- Manage product non-conformities
- Manage exemption, rework requests, corrective and preventive actions among suppliers
- Compile, analyze and communicate quality indicators
- Guide the quality inspectors in performing product inspection

Supplier Quality Management :

- Drive supplier Corrective Action Requests
- Manage Supplier Monitoring and ASL management
- Coordinate supplier quality audits
- Auditing key suppliers
- Participate in the selection and validation of new suppliers
- Work with R&D to design the controls on products and ensure that the necessary controls are installed
- Participate in risk assessments

Required Experience and Skills :
- Relevant Bachelor's degree
- 3 years' experience in a quality assurance or regulatory affairs role
- Good knowledge of ISO13485, 21CFR820, Medical Device Regulation (MDR).
- Language skills : good written and verbal English and French communications skills required.
- Experience with supplier quality auditing
- IT literacy, experience with using Microsoft Office applications
- Passion for quality and to do things right
- Based in Lyon or Full remote / 1 or 2 days per months onsite

Prefered Skills :
- Relevant Master's degree
- 5 years' experience in a quality assurance or a regulatory affairs role
- Certification as a lead auditor in ISO 13485
- Knowledge of ERP and quality systems, preferable Oracle and Windchill
- Strong communication skills