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- Tasks: Ensure product quality and compliance in a hands-on role within the medical device industry.
- Company: Join a leading medical device company focused on practical quality solutions.
- Benefits: Competitive salary, career growth opportunities, and a collaborative work environment.
- Why this job: Make a real impact on product quality while working closely with teams and suppliers.
- Qualifications: Experience in quality roles, knowledge of ISO standards, and strong communication skills.
- Other info: On-site position in Bicester with a focus on teamwork and problem-solving.
The predicted salary is between 36000 - 60000 £ per year.
We're looking for an experienced Principal Quality Associate to join our Quality team at our Bicester site, playing a key role in maintaining and strengthening quality and compliance across the business.
Reporting to the Compliance Director, you'll work closely with Quality Control, Manufacturing and Suppliers to ensure products meet regulatory and customer requirements — from incoming inspection through to goods release, audits, and corrective actions. This is a hands-on, influential role for someone who thrives in a regulated environment and enjoys turning quality requirements into practical, compliant processes.
What You'll Be Responsible For
- Supporting incoming inspection and goods release activities in collaboration with the Quality Control team
- Investigating product non-conformities and driving effective corrective and preventive actions (CAPA)
- Developing, implementing and maintaining compliant quality processes aligned to regulatory standards
- Planning, conducting and completing internal audits and supplier audits
- Supporting external audits, including preparation of documentation and participation during assessments
- Logging, investigating and documenting non-conformities (NCs) and CAPAs, ensuring timely resolution
- Monitoring and maintaining goods-in quality metrics, preparing data for quality and management reviews
- Conducting supplier evaluations and supporting supplier compliance meetings with relevant data and insights
- Coordinating Quality Control tasks to ensure product holds are resolved efficiently and compliantly
- Supporting quality activities at GBUK acquisition sites
- Undertaking additional quality-related tasks as required by the Head of Quality or Compliance Director
What We're Looking For
- Essential
- Experience working in a Quality role within the Medical Device industry
- Strong working knowledge of a recognised QMS (ISO 13485 or ISO 9001 as a minimum)
- Experience conducting internal audits (Lead Auditor level desirable)
- Hands-on experience with CAPA, non-conformities and root cause analysis
- Experience writing and implementing processes compliant with standards
- Excellent attention to detail with a structured, methodical approach
- Strong communication skills and the ability to work effectively across teams
- A proactive, problem-solving mindset with the ability to manage multiple priorities
- Desirable
- Knowledge and experience of MDR
- Experience or knowledge of FDA incident reporting
- Supplier audit experience
Why Join Us?
- A senior, influential quality role with real impact
- Close collaboration with manufacturing, suppliers and leadership
- A business that values practical quality, not just paperwork
- Opportunity to support quality across a growing organisation
Important: Candidates must be based in or able to commute to the Bicester area. This is an on-site role.
Principal Quality Associate in Oxford employer: GBUK
Contact Detail:
GBUK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Quality Associate in Oxford
✨Tip Number 1
Network like a pro! Reach out to folks in the medical device industry, especially those who work in quality roles. LinkedIn is your best mate here—connect, engage, and don’t be shy to ask for informational chats.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and CAPA processes. We want you to showcase your expertise, so have examples ready that demonstrate how you've tackled quality challenges in the past.
✨Tip Number 3
Don’t forget to research the company culture at the Bicester site! Understanding their approach to quality and compliance will help you tailor your responses during interviews and show that you’re genuinely interested.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re keen on joining our team and ready to make an impact in quality assurance.
We think you need these skills to ace Principal Quality Associate in Oxford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality roles, especially within the medical device industry. We want to see how your skills align with our needs, so don’t be shy about showcasing your hands-on experience with CAPA and audits!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality and compliance. We love seeing candidates who can connect their personal experiences to our mission at StudySmarter.
Showcase Your Problem-Solving Skills: In your application, highlight specific examples where you've tackled challenges in quality processes. We’re looking for proactive problem solvers who can manage multiple priorities, so let us know how you’ve done this in the past!
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’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at GBUK
✨Know Your Quality Standards
Make sure you brush up on ISO 13485 and ISO 9001 standards before the interview. Being able to discuss how you've applied these in your previous roles will show that you're not just familiar with the regulations, but that you can also implement them effectively.
✨Prepare for CAPA Discussions
Be ready to share specific examples of how you've handled corrective and preventive actions (CAPA) in the past. Think about a time when you identified a non-conformity and what steps you took to resolve it. This will demonstrate your problem-solving skills and hands-on experience.
✨Showcase Your Audit Experience
Since internal audits are a big part of this role, prepare to talk about your audit experiences. Highlight any lead auditor roles you've held and the outcomes of those audits. This will help illustrate your ability to maintain compliance and improve quality processes.
✨Communicate Effectively
Strong communication skills are essential for this position. Practice articulating your thoughts clearly and concisely. You might even want to role-play with a friend to get comfortable discussing complex quality topics in an easy-to-understand way.
