Senior Supplier Assurance Engineer

ABOUT ORGANOX:

Organ Ox 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. Organ Ox 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.

The Senior Supplier Assurance Engineer is responsible for leading and overseeing supplier quality activities across the Organ Ox supply chain to ensure compliance with applicable regulatory requirements where Organ Ox operate: USA, UK, EU, Canada, Australia and Switzerland and internal Quality Management System (QMS) processes.

The role provides technical leadership in supplier management activities including supplier qualification, approval, performance monitoring, and continuous improvement initiatives.

The Senior Supplier Assurance Engineer will act as a key interface between Quality Assurance, Operations, Procurement, Engineering, Product Quality, Supplier Development, and external suppliers to ensure effective control and monitoring of purchased products, outsourced processes, and supplier-related risks.

The role will support Organ Ox in maintaining compliance with ISO 13485, Code of Federal Regulations Title 21 parts 801, 806, 807, 820 under FDA QMSR, EU MDR 2017/745, UK Medical Device Regulations 2026, Canadian Medical Device Regulation SOR-98/282, Australian therapeutic Goods Act 1989, Therapeutic Good (Medical Devices) Regulations 2002 and Swiss Therapeutic Products Act TPA, SR 812.21, Medical Devices Ordinance MedDO, SR 812.213..

This is a flexible but predominantly on-site role based in Oxford to support close collaboration with Operations, Manufacturing, Engineering, and Quality teams, while ensuring effective oversight of supplier-related activities. The role will involve national and international travel for supplier visits.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Under direction from the Manager, Audit & QMS Training, the Senior Supplier Assurance Engineer will:

• Leading supplier qualification, approval, onboarding, and re-evaluation activities in accordance with Organ Ox procedures and applicable regulatory requirements.

• Acting as Subject Matter Expert (SME) for supplier quality management processes.
• Managing supplier performance monitoring activities including KPIs, trend analysis, supplier scorecards, responsiveness, quality metrics, and escalation activities where required.
• Monitoring supplier performance, distributor and quality agreements, quality metrics, and other relevant risk indicators to support the Auditing Team in determining when supplier audits or re-evaluation activities should be triggered in line with the risk-based supplier audit.
• Collaborating with Procurement, Engineering, Manufacturing, Product Quality, and Supply Chain teams to ensure supplier controls are appropriately implemented and maintained.
• Participating in Management Review activities by supporting supplier quality metrics, trends, risks, and escalation reporting.
• Supporting with the administering of Supplier Corrective Action Report (SCAR) process.
• Supporting the control and oversight of outsourced processes.
• Supporting supplier-related investigations associated with complaints, non-conformances, post-market surveillance activities,…