Participate in the development and deployment of the quality management system and report on its effectiveness and any need for improvement, both for the manufacturing side and for suppliers.

Main task and responsibilities

• Manage the supplier part of the quality management system
• Act as the company's point of contact for and manage the eQMS system
• Participate in the smooth running of the quality department and in maintaining the certifications of the company and its products.
• Actively contribute to the continuous improvement of our quality management system and organization
• Ensure effective communication with your external contacts, whether customers or suppliers, as well as other company departments, and support them in all matters relating to quality assurance.
• Make your contacts aware of the applicable regulatory requirements and the requirements of the quality management system, and actively contribute to the training of the company's employees in these aspects.
• Manage quality projects such as integrating new requirements into our QMS, validating manufacturing processes or handling CAPAs
• Participate in all Quality Department activities: conduct internal and supplier audits, handle customer complaints, manage documents and their modifications, manage control plans, analyze data, manage risks, define and monitor performance indicators.
• Coordinate the handling of internal and supplier non-conformities
• Collaborate with the technical department and production on all quality-related issues, such as problem-solving, process improvement and the development of new production equipment.

According to company needs and upon request of the Company Management or the direct supervisor, the employee should handle new tasks and responsibilities in accordance with her/his competencies.

Quality Management System (QMS)

The employee must be compliant with the Quality Management System requirements with which she/he is concerned. She/he must propose all potential evolution of these specifications, and to identify tools and resources to implement, in order to undertake all her/his responsibilities. These proposals are submitted to her/his direct manager.

Specific knowledge and required experience

• 5-10 years' professional experience in medical device quality
• Experience with an eQMS (electronic quality management system). Having participated in the implementation of an eQMS would be a plus
• Knowledge of the main standards and regulations applicable to our field (c:2016, Regulation (EU) 2017/745, 21 CFR Part 820 and other regulations applicable in MDSAP jurisdictions)
• Knowledge of statistical techniques relating to process control, controls and sampling plans
• Good knowledge of MS-Office tools (Word, Excel, PowerPoint)
• Good level of written and spoken in French