At a Glance
- Tasks: Own quality management activities and support regulatory compliance in a medical device environment.
- Company: Dynamic medical device company near Bristol with a focus on quality and innovation.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Gain hands-on experience in quality assurance while impacting global regulatory activities.
- Qualifications: 3 years in a quality role, knowledge of ISO 13485 and medical device regulations.
- Other info: Perfect for detail-oriented individuals seeking to advance their career in the medical field.
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 Bristol employer: GxPeople Global
Contact Detail:
GxPeople Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QARA Specialist in Bristol
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry on LinkedIn or at local events. We can’t stress enough how valuable personal connections can be in landing that QARA Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on ISO 13485 and GMP standards. We recommend creating a cheat sheet of key points and examples from your experience that showcase your expertise in quality management systems.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you, and tailor your approach to each one!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. We suggest mentioning something specific from your conversation to keep you fresh in their minds.
We think you need these skills to ace QARA Specialist in Bristol
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality roles, especially within medical devices. We want to see how your skills align with ISO 13485 and GMP, so don’t hold back on showcasing relevant projects!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance in the medical device sector. We love seeing candidates who can connect their personal motivations to our mission.
Showcase Your Problem-Solving Skills: In your application, mention specific examples where you've handled complaints or CAPAs. We’re looking for detail-driven individuals, so share how you approached challenges and what solutions you implemented.
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. Plus, it’s super easy!
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.