About this role
Reporting to the Senior Manager, Quality Assurance & Regulatory Affairs, the Senior Quality Engineering Specialist-Medical Device plays a key role in ensuring NDI products meet global regulatory requirements. In this role, you will support the full product lifecycle, including development, commercialization, and post market performance of medical devices. This role ensures products meet safety, performance, and regulatory requirements through the application of risk-based quality engineering principles and robust quality systems. You will act as a key quality partner across R&D, manufacturing, and regulatory teams—driving design quality, leading investigations, and ensuring compliance with ISO 13485, FDA QSR, and global regulatory requirements.