About the Role:
I'm partnered with an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. A commercial-stage business committed to improving transplantation outcomes throughout the world, their first product has been used to support more than 5,000 transplant operations globally, and they are growing fast.
They are now looking for a highly motivated and detail-oriented Quality Auditor to join their dynamic Quality team. In this pivotal role, you will lead and execute internal audits across their sites and conduct supplier audits to ensure products are safe and effective, verify full alignment with their Quality Management System, regulatory requirements, and industry best practices.
This is a business that takes quality seriously because what they make genuinely matters — and they're looking for someone who understands that distinction. If you think beyond checklists, see audits as an opportunity to strengthen a business rather than just verify it, and want to work somewhere where the work has real meaning, this is worth a conversation.
Key Responsibilities
- Plan and conduct internal and supplier product and manufacturing audits in accordance with quality agreements and regulatory requirements including ISO 13485:2016, FDA 21 CFR Part 820, and 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 findings to management, and monitor the effectiveness of corrective measures
- Support the development and implementation of action plans based on audit outcomes
- Support supplier qualification activities through audits for approval and periodic re-evaluation, ensuring adherence to quality agreement requirements and managing updates or revisions as necessary
- Partner with Procurement and Product Quality teams, providing audit data to support supplier qualification and re-evaluation processes, and collaborating to monitor supplier performance
- Foster strong working relationships with suppliers to drive continuous improvement and compliance
- Participate in and support external inspections and audits including BSI Notified Body and FDA
- Stay current with changes in applicable quality regulations and standards, providing training and guidance to internal teams as needed
Skills & Experience
- Audit Experience: Minimum 3 years in ISO 13485 QA-focused roles, including at least 1 year of hands-on practical auditing. Lead Auditor certification in ISO 13485, MDR or MDSAP desirable
- Interpersonal Skills: The ideal candidate is able to build rapport with auditees, anticipate reactions, and deal professionally with all situations. This role requires emotional intelligence and the ability to communicate the value of audits, making stakeholders feel at ease while encouraging open dialogue and genuine collaboration.
- Critical Thinking & Continuous Improvement Mindset: We're looking for someone 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: Strong attention to detail and demonstrable experience with process improvement
- Technical Proficiency: Proficient in Microsoft Office applications including Excel, PowerPoint, Visio and Word. Knowledge of MasterControl and Power BI is advantageous.
- Organisational Skills: Organised, detail-oriented, and able to multitask and prioritise responsibilities in a fast-paced environment
Qualifications
- University or college degree, preferably in life sciences, quality, or regulatory affairs, or an equivalent combination of education and experience
- Minimum 3 years of experience in medical device quality system auditing or equivalent
Location: Oxford-based, 3 days on-site with 2 days work from home per week. Ideally within a 50-mile / 1-hour commute of Oxford.
Travel: 10–15% across Europe and the US for supplier audits