- 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
- 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
- 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
- Validation experience (process, software or equipment)
- Internal or external auditing experience
- Risk management exposure (ISO 14971)
- Experience supporting global regulatory submissionsExperience supporting global regulatory submissions
- 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
- Stage 1: Virtual interview with Head of QA/RA
- Stage 2: Virtual interview with senior leadership
- Quick decision process following interviews
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Quality Specialist - Manchester - CAPU Search
Description
QA / RA Specialist
Manchester (Hybrid – 4 days onsite expected)
£42,000 – £50,000 + benefits
Medical Devices | Global Market Exposure
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?
The Role
You'll support Quality and Regulatory activities to ensure products meet global compliance requirements across multiple markets.
Key responsibilities include:
What They're Looking For:
Essential
Highly Desirable
Working Environment
Interview Process
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.
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Only for registered members Manchester
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Specialist Biomedical Scientist
Only for registered members Manchester
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Only for registered members Manchester
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Specialist, Service Delivery
Full time Only for registered members Manchester
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Catastrophic Injury Paralegal
Only for registered members Manchester
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Costs Court of Protection Team Leader
Only for registered members Manchester
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Orthodontist
Only for registered members Manchester
-
Specialist Biomedical Scientist
Full time Only for registered members Manchester
-
Orthodontist
Only for registered members Manchester
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Headteacher -
Only for registered members Manchester
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Glazing Project Manager
Only for registered members Manchester
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PMO Specialist
Only for registered members Manchester
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Technical Training Coordinator
Only for registered members Manchester
-
Specialist Doctor in Paediatric Urology
Only for registered members Manchester
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Data Management Specialist
Only for registered members Manchester