Summary of Position Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development and enforcement of internal systems and procedures to meet the local Quality Management System, ISO standards, FDA quality system regulation, and other regulatory requirements. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use. Essential Functions and Duties Plans, executes, and reports on equipment and process validation. Assists with training on quality and compliance concepts and best practices. Work with Quality team and cross‑functional teams to conduct quality investigations, identify root causes, and present potential solutions. Supports Treatment Planning teams in planning and execution of audits by e...