Job :

As part of strengthening its teams, our client, a player in the plastics sector specializing in medical devices, is looking for a Quality Manager.

Main tasks

Reporting to the Management, your main responsibilities will be:

• To lead and ensure the conformity of the Quality Management System (QMS) ;
• To ensure compliance with ISO 9001 and ISO 13485 standards ;
• To supervise document management and ensure the update of quality procedures and documents ;
• To manage non-conformities (NC), customer complaints, and corrective and preventive actions (CAPA) ;
• To prepare and lead internal, customer, and certification audits ;
• To monitor actions arising from audits ;
• To guarantee regulatory compliance applicable to medical devices ;
• To create, maintain, and update technical files ;
• To prepare and submit registration files to the competent authorities ;
• To handle communications with notified bodies and competent authorities ;
• To monitor quality KPIs and analyze system performance ;
• To participate in management reviews and produce quality reports ;
• To ensure regulatory and standard watch ;
• To train and raise awareness among employees about quality requirements and best practices ;

Required profile :

• Higher education degree (Bac+4/5) in Quality, QHSE, Industrial Engineering, Sciences, or a related field ;
• Professional experience of at least 3 to 5 years in a Quality role, ideally in medical devices, plastics, the pharmaceutical industry, or a regulated sector ;
• Good command of ISO 9001 standard ;
• Proven experience in ISO 13485 is a major asset ;
• Good knowledge of regulatory requirements applicable to medical devices ;
• Experience in managing NC, CAPA, audits, and document management ;
• Experience in preparing technical files or registration dossiers is highly desired ;
• Rigor, organization, analytical skills, and ability to work with various stakeholders ;
• Good communication and coordination skills.