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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 medical device regulations.
- Other info: Gain exposure to global regulatory activities in a supportive environment.
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 Newport employer: GxPeople Global
Contact Detail:
GxPeople Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QARA Specialist in Newport
✨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 personal connections can lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We recommend practising common QARA-related questions and having examples ready that showcase your experience with ISO 13485 and GMP. Confidence is key!
✨Tip Number 3
Don’t forget to follow up after interviews! A simple thank-you email can set you apart from other candidates. We suggest mentioning something specific from the interview to show your genuine interest.
✨Tip Number 4
Apply through our website for the best chance of landing that QARA Specialist role. We make it easy for you to showcase your skills and experience directly to hiring managers. Let’s get you that job!
We think you need these skills to ace QARA Specialist in Newport
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 the perfect fit for this QARA Specialist role. Share specific examples of your past experiences that relate to the job description and show us your passion for quality assurance.
Showcase Your Regulatory Knowledge: Since this role involves UK, EU, and global regulatory activities, make sure to mention any relevant experience you have. We love candidates who can demonstrate their understanding of regulations like MDR and FDA, so let us know what you’ve got!
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 us you’re keen on joining our team at StudySmarter!
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 that highlight your experience with audits, complaints, and CAPAs. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewer to see your impact.
✨Ask Insightful Questions
Come prepared with questions that demonstrate your interest in the company’s quality processes and regulatory challenges. This could be about their approach to supplier oversight or how they handle internal audits. It shows you’re engaged and thinking critically about the role.
✨Emphasise Your Problem-Solving Skills
Since the role requires a solutions-focused mindset, be ready to discuss how you've tackled challenges in previous positions. Highlight instances where you’ve improved processes or resolved issues effectively, as this will resonate well with the interviewers.
