Sr Quality System Engineer

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 our story? Don't hesitate, come and join us! About this opportunity – Sr Quality System Engineer - CAPA Description This fast-paced position will be responsible for sustaining production quality and the transfer of neurovascular products. You will have the responsibility to support and continuously improve current manufacturing processes, through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives. Job Responsibilities Coordinate and manage CAPA activities from initiation through closure, ensuring investigations, root cause analyses, corrective actions, preventive actions, and effectiveness checks are completed within established timelines. Lead cross-functional CAPA investigations involving Quality, Manufacturing, Engineering, R&D, Operations, and Supply Chain. Analyze quality data, trends, nonconformances, complaints, audit findings, process issues, and other sources of quality information to identify potential systemic issues and CAPA opportunities. Facilitate structured root cause investigations using tools such as 5-Why, Fishbone/Ishikawa, fault tree analysis, process mapping, and other appropriate problem-solving methodologies. Develop and document comprehensive root cause analyses and risk-based corrective and preventive action plans. Track CAPA action items, milestones, owners, and due dates; proactively communicate status and escalate overdue or high-risk activities. Coordinate implementation of corrective actions, including process changes, procedure updates, training, equipment improvements, supplier actions, and other appropriate controls. Develop and execute CAPA effectiveness checks to confirm that implemented actions have effectively addressed the identified problem and prevented recurrence. Manage and support the processing of internal Nonconformance Material Reports (NCMRs), including investigation, root cause analysis, disposition, corrective actions, and process improvements. <li data-leveltext="" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559