Position Overview
Roles & Responsibilities:
Develop quality assurance documentation for new product development and regulatory submissions. Maintain and improve quality system processes by identifying and correcting deficiencies. Engage in design, development, manufacturing, and risk management activities for new projects. Participate in design reviews, identify product risks, and ensure effective mitigation strategies. Define and validate design verification and validation test requirements. Complete final design verification and validation reports with statistical and graphical support. Promote efficient testing practices and support manufacturing process development. Utilize statistical analysis and problem-solving techniques to establish product acceptance limits. Review and approve inspection plans, routers, and product drawings for new products. Support product design transfers to ...