Senior QA Manager (M/F)

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. Reporting to the Site Quality Manager, you will work closely with the Site QA Manager, Site Directors/Operations Managers, the Global QA Manager and other site production and process control specialists to ensure full compliance of site production and process control processes. Actively participates in meetings with other site SMEs to share these opportunities Work closely with the operational function to improve the local quality management system and meet the site's new strategic needs Regularly monitor and evaluate quality assurance processes through close monitoring of data, and report any negative trends and/or opportunities for improvement to the site management team for appropriate action Ensure training is set up and efficiently implemented on assigned processes across the site Coordinate and facilitate implementation of process improvement projects across the site to standardize and simplify it and obtain cost savings working in close cooperation with other site Production and Process control SMEs, the site QA director, the site Director and the Global QS Director Support the site QA Director in audits for assigned process, preparing, and acting as follow up to internal and external audits Graduate in quality, engineering or associated fields required (preferably mechanical) Experience in working with medical device manufacturers or other equivalent combination of education and experience, experience to be applicable in production and process controls within a certified Quality Management System Fluent in English and French Knoledge of the Medical Devices Directive 93/42/EEC with its transposition into French law, the MDR 2017/45, main Medical Devices standards: