Quality Specialist - Manchester - CAPU Search

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    CAPU Search Manchester

    1 day ago

    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?

    • 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 submissionsExperience 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.


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Quality specialist