Sr. Quality Engineer

Our Senior Quality Engineer will proactively drive quality and compliance in design and development in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the design and development in early stages. As a key member of our team, you will actively drive design controls, design history file, risk management, design verification protocols and testing. This position also represents an opportunity to influence the design selection, optimization, specifications, and test development. You will enable patient safety, quality, and reliability in the early designs. This position will also play an active role in developing quality management system and ensure QMS compliance adherence. Responsibilities include: - Drive design controls deliverables, including DHF, design phase reviews, specification tracing to design outputs, design verification documentation, and risk management documentation. - Develop risk management files and associated deliverables, such as FMEA and hazard analysis. - Develop QMS infrastructure and processes per FDA Quality System Regulations and ISO 13485 and ensure compliance. - Prepare technical documentation for design control activities and regulatory submissions like V&V plans and reports, manufacturing instructions, and test methods. - Provide guidance on applicable standards and regulations and enable implementation of those into designs. - Develop quality inspection methods and processes.