Responsable Assurance Qualité (H / F)

Key Duties and Responsibilities :

Product Quality Management :

• Releasing finished products
• 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 :

• 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 :

• 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 :

• 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
• Experience with supplier quality auditing
• IT literacy, experience with using Microsoft Office applications
• Passion for quality and to do things right
• Based in Lyon (FR) or Full Remote possible with 1 / 2 days per months onsite