Senior Supplier Assurance Engineer

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 Senior Supplier Assurance Engineer is responsible for leading and overseeing supplier quality activities across the OrganOx supply chain to ensure compliance with applicable regulatory requirements where OrganOx 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 OrganOx 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.

Major Responsibilities

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 OrganOx 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, recalls, field actions, or manufacturing issues.
• Supporting with the assessment of supplier-related change notifications and supporting change control activities to ensure appropriate impact assessment and implementation.
• Supporting supplier quality aspects of design transfer, process validation, manufacturing transfer, and new product introduction activities.
• Supporting the development, implementation, and continuous improvement of supplier quality procedures, SOPs, work instructions, templates, and quality agreements.
• Supporting external inspections and audits including FDA, Notified Body, ISO certification, customer audits, and internal audits.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Skills & Experience

• Significant experience working within Quality Assurance or Supplier Quality in the medical device industry.
• Strong working knowledge of ISO 13485 and Code of Federal Regulations Title 21 parts 801, 806, 807, 820 and the European Union Medical Device Regulation 2017/745.
• Demonstrated experience in managing supplier quality systems.
• Experience managing supplier performance monitoring.
• Understanding of outsourced process controls, supplier risk management, and special process oversight.
• Experience supporting regulatory inspections and external audits.
• Strong understanding of GxP requirements and medical device regulatory expectations.
• Excellent communication, organisation, and stakeholder management skills.
• Strong problem-solving and root cause analysis skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Ability and willingness to travel domestically and internationally as required.

Qualifications

• University degree, preferably in Engineering, Bioscience, Life Sciences, Quality, or equivalent combination of education and experience.
• Minimum 5 years of experience in medical device industry

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.