Quality Project Manager - Healthcare BU

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

Qualifications

• 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

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.