Qms Senior Manager
il y a 2 semaines
**About Balt** Our purpose is to improve the lives of 150,000 patients in 2026. **Our story** Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries - and counting. We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space. We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives. **Why Join Balt? Join a passionate team, dedicated to making a difference.** - Working at Balt means giving meaning to your work Pride is a strong part of our identity. - We are a close-knit team, with strong mission, vision and values that guide our day-to-day. - Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success. - No matter the country, we take care of you. Would you like to be part of story? Don't hesitate and come and join us. **About this opportunity** Reporting directly to the Quality Manager he/she will lead the QMS team. You will be responsible for the quality management system in accordance with the standards and directives applicable to medical devices. You will work in close collaboration with the International Quality Managers of other Balt Group sites to harmonize practices. **Job responsibilities**: - Organize and carry out internal and external audits - Carry out management reviews - Participate in various product recall and/or safety notification campaigns, and carry out associated regulatory actions - Be responsible for the management of the QMS, including the management and monitoring of the relevant KPIs - NC, CAPA and doc control/Change control management - Be responsible for improving the quality system, compliance including system performance, and NCs in order to guarantee a high level of quality for customers - Be responsible for staff awareness and internal training on BALT EXTRUSION's quality system - Make proposals to management for improvements and optimization of the QMS - Define and coordinate the QMS team's workload in order to meet individual and team objectives - Act as "SME" for external and HHE audits - Participate in quality certification projects for the Montmorency site, while ensuring that current certifications are maintained, in collaboration with the quality team **Qualification requirements**: - Degree in quality, engineering or related field required (preferably mechanical) - Experience working with medical device manufacturers or other equivalent combination of education and experience, with experience applicable to production and process controls within a certified quality management system - Strong organizational, written communication and planning skills - Proven ability to successfully lead people and projects - Fluent in professional English L1-KN1
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