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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, collaborative environment, and opportunities for professional growth.
- Why this job: Make a real impact on product quality while working closely with teams and suppliers.
- Qualifications: Experience in quality roles, knowledge of QMS, and strong communication skills.
- Other info: On-site position in Bicester with a focus on career development.
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 Bicester employer: GBUK
Contact Detail:
GBUK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Quality Associate in Bicester
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Principal Quality Associate role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and CAPA processes. Be ready to share specific examples from your past experience that demonstrate your problem-solving skills and attention to detail. We want to see how you can turn quality requirements into practical solutions!
✨Tip Number 3
Don’t just apply anywhere—focus on companies that align with your values and expertise. Check out our website for openings at StudySmarter, where we value practical quality and compliance. Tailor your application to show how you can make an impact in our team!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Use this opportunity to reiterate your enthusiasm for the role and how your skills can contribute to maintaining quality and compliance at the company.
We think you need these skills to ace Principal Quality Associate in Bicester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your experience in quality roles within the medical device industry, especially any hands-on work with CAPA and non-conformities.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for the Principal Quality Associate role. Share specific examples of how you've successfully implemented compliant quality processes or conducted audits in the past.
Showcase Your Attention to Detail: In both your CV and cover letter, demonstrate your strong attention to detail. This could be through the clarity of your writing or by providing metrics from previous roles that showcase your impact on quality and compliance.
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 this exciting opportunity at StudySmarter!
How to prepare for a job interview at GBUK
✨Know Your Quality Standards
Make sure you brush up on your knowledge of ISO 13485 and ISO 9001. Be ready to discuss how you've applied these standards in your previous roles, especially in the medical device industry. This will show that you understand the regulatory landscape and can hit the ground running.
✨Prepare for CAPA Discussions
Since this role involves a lot of corrective and preventive actions, think of specific examples where you've successfully managed CAPAs or non-conformities. Be prepared to explain your thought process and the outcomes, as this will demonstrate your problem-solving skills.
✨Showcase Your Audit Experience
If you've conducted internal audits before, be ready to share your experiences. Talk about the challenges you faced, how you overcame them, and what you learned. This will highlight your hands-on experience and ability to maintain compliance.
✨Communicate Effectively
Strong communication skills are key in this role. Practice articulating your thoughts clearly and concisely. Think about how you would explain complex quality processes to someone outside the field, as this will showcase your ability to work across teams.
