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- Tasks: Own ISO 13485 QMS activities and support regulatory compliance in medical devices.
- Company: Dynamic medical device company near Bristol with a hybrid work model.
- Benefits: Flexible working, competitive salary, and opportunities for professional growth.
- Why this job: Deepen your quality experience while making a real impact in healthcare.
- Qualifications: 3 years in a Quality role with knowledge of ISO 13485 and GMP.
- Other info: Gain exposure to global regulatory activities and enhance your career.
The predicted salary is between 36000 - 60000 £ per year.
A great opportunity for a QARA professional to step into a hands-on role within a medical device environment.
Hybrid (up to 2 days WFH) near Bristol.
This role sits at the heart of manufacturing, supplier oversight and regulatory support, with a strong quality focus (70%) and exposure to UK, EU and global regulatory activities (30%).
What you’ll be doing:
- Day-to-day ownership of ISO 13485 / GMP-aligned QMS activities
- Supporting validation (equipment, process & software)
- Managing and supporting internal, supplier & Notified Body audits
- Handling complaints, RCA and CAPAs
- Maintaining controlled documentation within an eQMS
- Supporting supplier quality and production quality activities
- Contributing to regulatory documentation, PMS and labelling reviews
What we’re looking for:
- 3 years’ experience in a Quality role within medical devices
- Working knowledge of ISO 13485, GMP and medical device regulations (MDR / UK MDR / FDA exposure a plus)
- Experience across validation, audits, complaints and document control
- Someone confident working independently, detail-driven and solutions-focused
This is a strong role for someone looking to deepen their medical device quality experience while gaining broader regulatory exposure.
QARA Specialist in Bath employer: GxPeople Global
Contact Detail:
GxPeople Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QARA Specialist in Bath
✨Tip Number 1
Network like a pro! Reach out to professionals in the QARA field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and GMP. We recommend having specific examples ready that showcase your experience with audits and complaints handling.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds.
✨Tip Number 4
Apply through our website! We’ve got loads of resources to help you ace your application and connect with the right opportunities in the medical device sector.
We think you need these skills to ace QARA Specialist in Bath
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QARA Specialist role. Highlight your experience with ISO 13485, GMP, and any relevant regulatory knowledge. We want to see how your background fits perfectly with what we’re looking for!
Showcase Your Skills: In your cover letter, don’t just list your skills—show us how you’ve used them in real situations. Talk about your experience with audits, complaints, and document control. We love seeing concrete examples of your problem-solving abilities!
Be Clear and Concise: When writing your application, keep it clear and to the point. Use bullet points where possible to make it easy for us to read. We appreciate a well-structured application that gets straight to the heart of your qualifications.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy and ensures your application goes directly to us. Don’t miss out on this great opportunity—hit that apply button!
How to prepare for a job interview at GxPeople Global
✨Know Your Standards
Make sure you brush up on ISO 13485 and GMP regulations before the interview. Being able to discuss these standards confidently will show that you’re not just familiar with them, but that you understand their importance in a medical device environment.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve managed audits, handled complaints, or contributed to regulatory documentation. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Ask Insightful Questions
Think of questions that demonstrate your interest in the company’s quality processes and regulatory challenges. For instance, ask about their approach to supplier oversight or how they handle CAPAs. This shows you’re engaged and thinking critically about the role.
✨Be Detail-Driven
Since this role requires a strong focus on detail, be prepared to discuss how you ensure accuracy in your work. Whether it’s through maintaining controlled documentation or supporting validation activities, highlight your methods for staying organised and thorough.
