- Location
- Mantes, France
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Manager
- Source
- Workday
Description
About Linxens
Linxens is a global leader in micro-connectors, module packaging, antennas & inlays, and secure ID solutions, with over 40 years of innovation. Headquartered in Paris, France, we operate R&D centers and production sites across Germany, France, Sweden, China, India, Singapore and Thailand.
Our solutions serve industries such as telecommunications, finance, transportation, hospitality, e-government, healthcare, and the Internet of Things (IoT).
Our employees’ expertise and know-how allow us to continually reinvent ourselves and meet our customers’ evolving needs, helping them grow and innovate. Therefore, we invest in developing our employees’ skills and career growth.
Working for Linxens means investing in your future. Our growth is creating great opportunities!
Below is the job description for open position
Responsibilities
Coordinate site-level healthcare projects (NPI, changes, transfers, design evolutions)
Ensure compliance with ISO 13485, FDA QSR, and MDSAP
Coordinate cross-functional teams (Production, R&D, Quality, Supply Chain, IT)
Integrate projects into operational site activities
Drive continuous improvement, gap analysis, and action plans
Lead customer complaint handling processes and quality controls
Support internal/external audits and regulatory inspections
Ensure validation and compliance of regulated software systems
Participate in supplier selection and qualification
Secure operational integration of developed projects into site activities.
Participate in coordination meetings with HLC interfaces and the VP RAQA HLC.
Ensure robustness of healthcare practices at site level.
Perform gap analyses and deploy the necessary action plans within a continuous improvement approach
Define and implement a structured HLC customer complaint handling process
Conduct internal audits and actively contribute to external audit preparation
Qualification
6+ years’ experience in Quality & Project Management in a medical device industry
Degree in Engineering (Mechanical, Biomedical, or related)
Strong experience in RAQA, ISO 13485, QSR, MDSAP
Excellent communication and project management skills
High attention to detail and problem-solving mindset
Fluent in French and English
Join Linxens to work in a multicultural environment, collaborating with leading tech innovators and making a global impact on technology.
LINXENS is an equal-opportunity employer that strictly prohibits unlawful or unethical discrimination. Moreover, as part of our CSR Vitality program, we have committed to recruit, hire, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity, national origin, age, mental/physical disability, marital status, or any other characteristic protected by law.
