Manager, Quality

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision‑making for a product’s entire lifecycle. Your work will involve you optimizing post‑market quality to impact patients around the world with pioneering technology. In this role specifically you will work to improve and implement quality systems processes, including applications, documentation and training. The role is office based in our office in Guyancourt, with remote working included and it will require approximately 10% availability to travel. How you’ll make an impact: Lead the definition, deployment, and continuous improvement of the regional quality policy for the country Presentation Information Promotion (PIP) activities, ensuring alignment with company objectives, the French Charter, and certification requirements. Integrate regulatory and business needs from THV and TMTT into the quality strategy. Oversee the implementation and effectiveness of the QMS for PIP and regional business units, ensuring robust document management, training, and traceability. Drive harmonization and best practices across THV and TMTT, leveraging cross‑functional collaboration. Ensure all PIP activities and regional business processes comply with internal and external standards (e.g., ISO 13485, FDA 21 CFR Part 820/11). Lead internal audits, manage corrective and preventive actions, and support external audits and certification processes. Partner with business unit leaders, regulatory affairs, legal, marketing, sales, and other functions to embed a strong quality culture. Oversee training programs for employees on regulatory and product‑specific topics, ensuring ongoing competency. Assist EU quality business partner for THV and TMTT, supporting product lifecycle management, complaint handling, risk management, and post‑market surveillance. Facilitate cross‑functional initiatives to improve quality outcomes and patient safety. Lead the generation, analysis, and automation of quality metrics for PIP and business units. Use data‑driven insights to identify trends, drive process improvements, and report on quality performance to senior management. Foster a culture of quality and compliance through cross‑functional teamwork, knowledge sharing, and active participation in regional and global quality forums. What you’ll need (Required): Master’s degree in Biomedical Engineering, Life Sciences, or related field 7 years’ experience on quality and/or manufacturing environment in the medical device industry Experience with Quality Systems and Audits Preferred Fluent in both French and English What else we look for (Preferred): Proven successful project management skills Proven expertise in MS Office Suite Excellent facilitation and presentation skills, showing great communication skills Excellent problem‑solving, organizational, analytical and critical thinking skills Excellent documentation and interpersonal relationship skills including negotiating and relationship management skills Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards Extensive knowledge and understanding of medical or pharmaceutical regulations as relating to documentation Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971) Ability to transfer essential knowledge and mentor other team members on specialized skills Strict attention to detail Ability to interact professionally with all organizational levels and proactively elevate issues to appropriate levels of management in the organization Ability to manage competing priorities in a fast‑paced environment Ability to represent leadership on sections of projects within a specific area interfacing with project managers and quality systems team #J-18808-Ljbffr