QualityEngineer,Validation

**ABOUT ORGANOX:** OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. **Position Summary** The Quality Engineer, Validation is responsible for ensuring that manufacturing processes and test methods are robust, repeatable, and capable of consistently meeting defined requirements. Working within the Product Quality team, the role leads process and test method validation activities across OrganOx and its suppliers. With a focus on providing Quality support for validation of new manufacturing processes (injection moulding, assembly, sterilisation, packaging), as well as sustaining existing processes at suppliers. It sits at the point where design intent is translated into controlled, reliable execution, in line with the principles of ISO 13485 and risk management expectations of ISO 14971. By working closely with Design Assurance, Operations and Supplier the Validation Quality Engineer takes defined inputs, understands risk through tools such as pFMEA, and builds validation strategies that provide clear, objective