Senior Design Quality Engineer

Overview: The Senior Quality Engineer for Design will leverage expertise in quality engineering practices to ensure adherence to regulatory standards and internal company processes. This role focuses on optimizing the product development cycle, as well as supporting both internal and external manufacturing operations, while overseeing the distribution of finished products. Responsibilities: Develop and implement solutions for quality assurance, risk management, and design controls. Lead product design activities, including feasibility studies, engineering evaluations, and design reviews. Create and maintain risk management files, including hazard analyses and FMEAs, in compliance with ISO 14971. Develop quality specifications, test methods, inspection criteria, and sampling plans. Oversee test method validation and new product introduction, ensuring smooth design transfer to manufacturing. Provide ongoing support for production issues, driving continuous improvement in manufacturing processes. Review and revise product documentation, ensuring compliance with regulatory standards. Prepare documentation for global regulatory submissions and registrations. Apply knowledge of Software Development Life Cycle (SDLC) and Usability Engineering in compliance with IEC 62304 and IEC 62366. Manage supplier qualification processes and support additional duties as needed. Qualifications: Bachelor’s degree in Engineering or a related scientific discipline with at least 5 years of experience in quality engineering, product manufacturing, or R&D, or a Master’s degree with 4 years of relevant experience. Practical experience with design assurance processes, including managing design controls, verifying and validating design outputs, and developing test methods during the design phase. Proficiency in quality assurance principles, including risk management, statistical analysis, and design testing. Strong knowledge of regulatory frameworks, including ISO 14971, IEC 62304, and IEC 62366, and their application to product development and manufacturing.