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- Tasks: Support Quality and Regulatory activities for medical devices, ensuring global compliance.
- Company: Join a growing global MedTech company with a collaborative culture.
- Benefits: Competitive salary, hybrid working, and opportunities for rapid career growth.
- Why this job: Gain valuable experience in QA/RA while making a real impact in the MedTech industry.
- Qualifications: Degree in Engineering or Life Sciences and 3+ years in Quality roles.
- Other info: Dynamic team environment with exposure to global markets and regulatory processes.
The predicted salary is between 36000 - 60000 £ per year.
A medical device SME are looking to hire a QA/RA Specialist due to expanding global manufacturing and continued commercial growth. This role is heavily Quality-focused, with exposure to Regulatory activities, making it ideal for someone looking to broaden their experience across the full product lifecycle.
Why This Role?
- Join a growing global MedTech company expanding manufacturing across Europe, Mexico and Asia
- Work directly alongside the Head of QA/RA in a small, high-impact team
- Gain exposure across supplier qualification, validation, audits and regulatory submissions
- Perfect for someone who enjoys variety and wants to accelerate their development in QA/RA
The Role
You’ll support Quality and Regulatory activities to ensure products meet global compliance requirements across multiple markets. Key responsibilities include:
- Maintaining and improving the ISO 13485 QMS
- Supporting MDSAP compliance (FDA, Health Canada)
- Supplier quality oversight and qualification activities
- Reviewing and supporting process, software and equipment validation
- Supporting internal and external audits
- Supporting regulatory submissions and product lifecycle compliance
- Maintaining technical documentation including DHF and Technical Files
- Supporting risk management activities aligned with ISO 14971
- Working cross-functionally with manufacturing partners globally
What They’re Looking For:
- Essential Degree in Engineering, Life Sciences or related discipline
- Experience working within ISO 13485 regulated medical device environments
- Exposure to MDSAP / FDA / Health Canada compliance
- Around 3+ years’ experience in Quality or QA/RA roles
- Highly Desirable Validation experience (process, software or equipment)
- Internal or external auditing experience
- Risk management exposure (ISO 14971)
- Experience supporting global regulatory submissions
Working Environment
- Hybrid working model (Manchester office being established)
- Collaborative, close-knit international team
- Opportunity to take ownership and broaden responsibilities quickly
- Exposure to global manufacturing and regulatory markets
Interview Process
- Stage 1: Virtual interview with Head of QA/RA
- Stage 2: Virtual interview with senior leadership
- Quick decision process following interviews
If you’re someone who enjoys learning, wants exposure across both QA and Regulatory, and likes working in a growing MedTech environment where you can genuinely influence outcomes — this is a strong opportunity to accelerate your career.
Quality Specialist in Manchester employer: CAPU Search
Contact Detail:
CAPU Search Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist in Manchester
✨Tip Number 1
Network like a pro! Reach out to people in the MedTech industry, especially those working in QA/RA roles. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for those interviews! Research the company’s products and their compliance standards. Show them you’re not just a fit for the role but also passionate about their mission in the medical device space.
✨Tip Number 3
Practice your STAR technique for behavioural questions. Think of specific situations where you’ve demonstrated your skills in quality assurance or regulatory affairs. This will help you stand out during interviews!
✨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 proactive about their job search.
We think you need these skills to ace Quality Specialist in Manchester
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Specialist role. Highlight your experience with ISO 13485 and any relevant QA/RA roles you've had. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the MedTech industry and how your skills can contribute to our team. We love seeing genuine enthusiasm!
Showcase Relevant Experience: When filling out your application, be sure to showcase any experience you have with regulatory submissions or audits. We’re keen on candidates who can demonstrate their understanding of compliance in the medical device sector.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at CAPU Search
✨Know Your ISO Standards
Make sure you brush up on ISO 13485 and ISO 14971 before the interview. Being able to discuss how these standards apply to quality management systems and risk management will show that you're not just familiar with the regulations, but that you can actively contribute to maintaining compliance.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in QA/RA, especially any work related to MDSAP or FDA compliance. 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 role and the company. Inquire about their current challenges in supplier qualification or regulatory submissions. This shows that you’re thinking critically about the position and how you can add value.
✨Emphasise Your Collaborative Spirit
Since this role involves working cross-functionally, be ready to discuss how you've successfully collaborated with different teams in the past. Highlight any experiences where you’ve taken ownership of projects or contributed to team success, as this aligns well with their close-knit team environment.
