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- Tasks: Ensure product quality and compliance in a hands-on role with real impact.
- Company: Join a leading company in the Medical Device industry focused on practical quality.
- Benefits: Competitive salary, collaborative environment, and opportunities for professional growth.
- Why this job: Make a difference in quality assurance while working closely with teams and suppliers.
- Qualifications: Experience in Quality roles, knowledge of QMS, and strong communication skills.
- Other info: Dynamic role with opportunities to influence quality across a growing organisation.
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:
- 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)
- 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
- Knowledge and experience of MDR
- Experience or knowledge of FDA incident reporting
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.
Principal Quality Associate employer: GBUK
Contact Detail:
GBUK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Quality Associate
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working 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 practising common questions related to quality assurance and compliance. We recommend using the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your experience effectively.
✨Tip Number 3
Showcase your hands-on experience! Bring examples of how you've tackled CAPAs or non-conformities in past roles. Real-life stories resonate well with interviewers and demonstrate your problem-solving skills.
✨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 genuinely interested in joining our team.
We think you need these skills to ace Principal Quality Associate
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 non-conformities!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how you can contribute to our team. We love seeing candidates who can connect their 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 someone with a proactive mindset, so share those moments when you turned a problem into a solution!
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
Since this role involves a lot of CAPA work, be ready to share specific examples of how you've handled non-conformities in the past. Think about the steps you took to investigate issues and how you implemented corrective actions. This will demonstrate your hands-on experience and problem-solving skills.
✨Showcase Your Communication Skills
This position requires strong communication across teams, so be prepared to discuss how you've collaborated with Quality Control, Manufacturing, and Suppliers. Share examples of successful teamwork and how you’ve navigated challenges in a regulated environment.
✨Bring Data to the Table
Since monitoring quality metrics is key, consider bringing some data or examples of quality metrics you've worked with. Discuss how you used this data to drive improvements or support audits. This will highlight your analytical skills and attention to detail.
