Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead internal and supplier audits to ensure product safety and compliance.
- Company: Innovative global medical device company dedicated to saving lives.
- Benefits: Flexible work arrangement with 3 days on-site and 2 days remote.
- Why this job: Make a real impact in healthcare by improving transplantation outcomes.
- Qualifications: 3+ years in ISO 13485 QA roles; strong interpersonal and analytical skills.
- Other info: Dynamic team environment with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
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.
- 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.
- 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.
Quality Auditor in Oxford employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Auditor in Oxford
✨Tip Number 1
Network like a pro! Reach out to people in the medical device industry, especially those who work at companies you're interested in. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s mission and values. Since this role is all about quality and making a difference, show them you’re passionate about their cause and how your skills align with their goals.
✨Tip Number 3
Practice your audit scenarios! Think of real-life examples where you've improved processes or handled challenges. This will help you demonstrate your critical thinking and continuous improvement mindset during interviews.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our platform.
We think you need these skills to ace Quality Auditor in Oxford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Auditor role. Highlight your audit experience, especially with ISO 13485 and any relevant certifications. We want to see how your skills align with our mission to improve transplantation outcomes.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Share why you’re passionate about quality in the medical device industry and how you can contribute to our team. We love seeing candidates who think beyond checklists and understand the real impact of their work.
Showcase Your Interpersonal Skills: In this role, building rapport is key. Use your application to demonstrate your interpersonal skills and emotional intelligence. We’re looking for someone who can communicate effectively and foster collaboration, so let that shine through!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. Plus, we love seeing applications come in through our own platform!
How to prepare for a job interview at Skills Alliance
✨Know Your Standards
Familiarise yourself with ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR. Being able to discuss these standards confidently will show that you understand the regulatory landscape and can navigate it effectively.
✨Showcase Your Audit Experience
Prepare specific examples from your past audit experiences that highlight your critical thinking and problem-solving skills. Be ready to explain how you've identified areas for improvement and implemented corrective actions in previous roles.
✨Build Rapport
Demonstrate your interpersonal skills by discussing how you’ve successfully built relationships with auditees in the past. Highlight your ability to communicate effectively and foster open dialogue during audits.
✨Emphasise Continuous Improvement
Talk about your mindset towards continuous improvement. Share instances where you’ve gone beyond checklists to enhance processes and outcomes, showing that you see audits as opportunities for growth rather than just compliance checks.