Linxens

Quality Project Manager - Healthcare BU

Mantes Full time

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.