Quality Auditor

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). Its 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.

Position Summary: As part of our continued global growth, we are seeking a highly motivated and detail-oriented Quality Auditor to join our dynamic Quality team. In this pivotal role, you will lead and execute internal audits across our sites and conduct supplier audits to ensure OrganOx products are safe & effective, verify full alignment with our Quality Management System, regulatory requirements, and industry best practices. You will be instrumental in identifying process improvement opportunities and driving continuous improvement initiatives throughout the organization and our supply chain.

The ideal candidate brings deep knowledge of medical device regulations including FDA QSRs and the EU Medical Device Regulation, ISO 13485, and, along with a proven ability to conduct value-added audits that go beyond compliance to strengthen operational excellence. This is an on-site role in Oxford, with flexibility, and a minimum of 10% travel across the UK, Europe, and the US to visit OrganOx and supplier sites.

Major Responsibilities: Under direction from the Manager, Audit & QMS Training the Quality Auditor will be responsible for:

• Plan and conduct internal and supplier product and manufacturing audits in accordance with OrganOx quality agreements, regulatory requirements (e.g., ISO 13485:2016, FDA 21 CFR Part 820, EU MDR).
• Identify areas for improvement within the QMS and supplier systems and support the implementation and verification of corrective actions.
• Develop and deliver audit reports, communicate, and follow up on findings to management, and monitor the effectiveness of corrective measures.
• Support supplier qualification activities through audits for approval and periodic re-evaluation, ensuring adherence to quality agreement requirements and managing updates or revisions to the agreements as necessary.
• Partnering with different relevant departments such as Procurement and Product Quality by providing audit data to support supplier qualification and re-evaluation processes, and collaborating with them to monitor supplier performance and identify the need for further actions.
• Foster strong working relationships with suppliers to drive continuous improvement and compliance.
• Participate in and support external inspections and audits (e.g., BSI Notified Body, FDA).
• Stay current with changes in applicable quality regulations and standards, providing training and guidance to internal teams as needed.
• Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies.

Requirements: Skills & Experience

• Strong Interpersonal Skills: The Internal Auditor we are looking for is able to build rapport with auditees, able to anticipate reactions and deal professionally with all situations, able to create a positive, and respectful audit environment.
• Critical Thinking & Continuous Improvement mindset: We are looking for an auditor who thinks beyond checklists; someone who can look at processes end-to-end, ask the right questions, and spot practical ways to improve efficiency, compliance, and overall performance; benefiting both quality and business outcomes.
• Analytical abilities, attention to detail, and experience with process improvement.
• Technical Proficiency: Proficient in Microsoft Office applications such as Excel, PowerPoint, Visio, Word, knowledge of Master Control and Power BI is advantageous.
• Organizational Skills: Organized, detail-oriented, and able to multi-task and prioritize responsibilities.
• Audit Experience: Experience in quality audits preferred, Lead auditor certification desired in ISO-13485, MDR, MDSAP.

Qualifications: University or College degree, preferably in life sciences or quality/regulatory, or equivalent combination of education and experience. Demonstrable experience in medical device quality system auditing or equivalent combination of education and experience.

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.