Manager, Quality
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Job Location:
Guyancourt - France
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing post-market quality to impact patients around the world with pioneering this role specifically you will work to improve and implement quality systems processes including applications documentation and training. The role is based in our Guyancourt office with remote work included and approximately 10% travel. We are also open to fully remote candidates who can accommodate a higher travel requirement of up to 25%.
How youll 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 youll need (Required):
Masters 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 escalate 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
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more
