Quality Auditor -

Oxford

About the Role

I’m partnered with an innovative, fast-paced global medical device company with a mission to save lives by ensuring every donated organ counts. This commercial-stage business is committed to improving transplantation outcomes worldwide, and their first product has already supported more than 5,000 transplant procedures globally. With continued growth and expanding operations, they are now looking to strengthen their Quality team.

They are seeking a highly motivated and detail-oriented Quality Auditor to join their dynamic organisation. In this role, you will lead and execute internal audits across multiple sites and conduct supplier audits to ensure products remain safe, effective, and compliant with the company’s Quality Management System, regulatory requirements, and industry standards.

This organisation takes quality seriously because the work they do has a direct impact on patient outcomes. They are looking for someone who sees audits not simply as a compliance exercise, but as an opportunity to drive continuous improvement, strengthen systems, and support business excellence.

Key Responsibilities

• Plan and conduct internal and supplier product and manufacturing audits in line with quality agreements and regulatory requirements including ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR

• Identify improvement opportunities within the Quality Management System (QMS) and supplier processes, supporting corrective and preventive actions

• Prepare and deliver audit reports, communicate findings to management, and monitor the effectiveness of corrective actions

• Support the development and execution of action plans resulting from audit outcomes

• Conduct supplier qualification and re-evaluation audits, ensuring compliance with quality agreements

• Collaborate with Procurement and Product Quality teams to support supplier performance monitoring and qualification activities

• Build strong working relationships with suppliers to encourage continuous improvement and regulatory compliance

• Support external inspections and audits including Notified Body and FDA inspections

• Stay up to date with changes in quality regulations and standards, sharing knowledge and providing guidance internally where required

Skills & Experience

• Audit Experience: Minimum 3 years’ experience in ISO 13485 quality environments, including at least 1 year of practical auditing experience. Lead Auditor certification (ISO 13485, MDR, or MDSAP) is desirable.

• Interpersonal Skills: Ability to build rapport with auditees, communicate effectively, and encourage open and constructive dialogue.

• Critical Thinking & Continuous Improvement: Ability to analyse processes end-to-end, identify improvement opportunities, and support operational efficiency and compliance.

• Analytical Ability: Strong attention to detail with experience identifying process improvements.

• Technical Proficiency: Proficient with Microsoft Office (Excel, Word, PowerPoint, Visio). Experience with MasterControl or Power BI is advantageous.

• Organisational Skills: Able to manage multiple priorities in a fast-paced environment while maintaining accuracy and structure.

Qualifications

• University or college degree in Life Sciences, Quality, Regulatory Affairs, or a related field (or equivalent experience)

• Minimum 3 years’ experience in medical device quality system auditing or similar roles

Location & Travel

• Location: Oxford – 3 days onsite / 2 days remote

• Ideally located within a 50-mile / ~1 hour commute

• Travel: Approximately 10–15% across Europe and the US for supplier audits