Director, Quality Operations
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About The Position
The Director of Quality Operations is responsible for the production quality function at the Lewisville, Texas site, ensuring manufacturing and inspection programs and processes are in place to ensure compliance with Orthofix Quality Standards, FDA, and applicable OUS regulations. The Director of Quality Operations is responsible for leadership and supervision of the manufacturing quality team including incoming inspection, product release, monitoring of in-house and supplier operations, calibration monitoring, and product distribution. The Director of Quality Operations will support and drive improvements across the entire lifecycle of products, including manufacturing process design, inspection plans, change control, deviations, complaint management, and performance data review. In addition, the Director of Quality Operations partners closely with other functions to ensure all decisions and actions are determined through the application of good science, risk management, and the most current regulatory expectations.
