Senior Quality Engineer
This role involves owning and improving the Quality Management System (QMS) within a medical device manufacturer, ensuring compliance with ISO 13485, EU MDR, and FDA regulations. The engineer will lead QMS processes including deviation management, CAPA, document control, and internal audits, while collaborating with operations, regulatory, and supply chain teams. Key responsibilities include supplier audits, root cause analysis, and driving continuous quality improvements in a highly regulated environment.