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 fulfill 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 Product Quality Engineer develops andoversees product and device inspection and acceptance activities for the OrganOx Metra, a Class III medical device. These activities include but are not limited to development of first article inspection processes, oversight of incoming inspection, responsible for nonconforming material and material review board, and product acceptance. This position works closely with contracted manufacturers, suppliers, and quality inspectors to ensure day-to-day execution of these critical business processes and lead improvements of these processes. This position involves supervisory responsibilities of Quality Inspectors and Technicians, as well as executing continuous improvement initiatives to improve product quality. This is an onsite position in Oxford with flexibility. 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 Senior Manager, Product Quality Engineering, the Senior Product Quality Engineer may be responsible for: Leadership and Team Development Day to day management of quality inspectors and technicians Define team goals in collaboration with the Sr. Manager, Product Quality Engineering Manage performance reviews and development plans for quality inspectors and technicians Day to Day management and monitoring of KPIs related to product quality (Ex- Investigation Aging, NC aging and resolution) Promote a culture of accountability, collaboration and continuous improvement. Technical Quality Engineering Oversight Conducting hands on oversite of the device acceptance process, ensuring device acceptance targets are met. Conducting hands-on oversight of the incoming inspection process, ensuring inspection targets are met. Development of first article inspection processes Conduct root cause investigations regarding non-conforming product Lead and support continuous process improvements related to device acceptance and incoming inspection Leading Material Review Board and dispositioning inspected product Execution of non-conformances Trending and analysis of non-conformance data to drive decisions Support updates to specification templates and inspection criteria Support development of inspection fixtures and tooling Ensure calibration records are up to date Lead and support quality process improvements, identify systemic issues and drive continuous improvement initiatives Regulatory Compliance & QMS Ensure adherence to regulatory standards: FDA 21 CFR 820, ISO 13485, EU MDR, MDSAP, etc Support regulatory submissions, internal audits, and external inspections (e.g., FDA, Notified Body). Maintain and improve quality processes and documentation within the QMS. Cross-Functional Collaboration Participate in Design Reviews and Change Control Boards. Collaborate with suppliers and contract manufacturers on quality standards, audits, and issue resolution. Communicate diligently with evidence-based communication to management and peers Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies Requirements Skills & Experience Significant related quality engineering work experience within the medical device field or other highly regulated industry required Knowledge of regulatory and quality standards: FDA QSR, ISO 13485, ISO 14971, EU MDR. Demonstrable technical quality engineering skills including root cause analysis, test method development, fixture development, and project management Experience working with nonconformances, first article inspections, CAPAs and SCARs Proven track record of problem solving and improving quality processes Experience using statistics and data analysis to solve quality problems Ability to travel internationally up to 30% to support contract manufacturers and suppliers, visit OrganOx sites, and visit customer sites Qualifications Bachelor’s degree in Engineering, Life Sciences, or a related technical field required ASQ Certifications (CQE, CMQ/OE, CQA) preferred Six Sigma Green Belt or Black Belt Certification preferred Benefits 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.