🔬 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?
* 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.