About this Healthcare Site Quality & Project Leader role at Linxens
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 the integration of healthcare projects (NPI, changes, transfers, design evolutions, process changes).
Ultimately responsible for assuring the compliance with ISO 13485, MDR and QSR (FDA, Quality System Regulation) requirements connected to the site and other global regulatory requirements.
Ensure the involvement of key functions (Production, R&D Engineering, Quality, Supply Chain, IT, HR).
Secure operational integration of developed projects into site activities.
Participate in coordination meetings with HLC interfaces and the Head of RA QA 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.
Define and implement appropriate controls to ensure product quality.
Conduct internal audits and actively contribute to external audit preparation.
Ensure applicable software systems comply with regulatory requirements and are properly validated
Act as Quality representative for HLC customers to capture requirements and integrate them into site working methods.
Participate in supplier selection and qualification within project definition phases.
Qualification
Strong RA QA background in medical device industry - ISO13485, MDR, FDA 21 CFR part 820/QSR/QMSR, MDSAP and other applicable global regulatory requirements.
Academic degree in engineering, life sciences or similar relevant work experience.
Minimum 7 years experience of working with quality assurance and/or regulatory affairs in the medical device business
Minimum 5 years of people leadership experience
Lean Six sigma green belt or black belt
Strong oral and written communication skills in 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.
