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    • This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices.
    • The role ensures that controlled documents, quality records and agreed quality-system workflows are maintained accurately, progressed in a timely manner and…
    • Monitor and provide feedback on supplier quality performance and incoming product quality trends.
    • Experience using quality management systems.
    • 2–5 years' experience in regulatory affairs, quality assurance or compliance within medical device or pharmaceutical environments.
    • Support quality assurance processes throughout the manufacturing operation.
    • Experience carrying out dimensional inspection and quality checks.
    • Support the Site Quality Manager with budgeting, monitoring and controlling medical QC expenditure.
    • Manage shift analysts, the analytical support chemists and…
    • Significant QA leadership in clinical quality, PV quality or both, including leading global teams in a complex matrix; experience across both GCP and GVP is…
    • Communicate inspection results and quality issues to production supervisors, technicians, and quality inspectors in a timely and effective manner.
    • Additional certifications in quality management or medical device compliance.
    • Experience with Class III medical device validation, testing or quality assurance.
    • Manage document control, quality records and quality metrics.
    • Coordinate supplier quality activity and monitor emerging quality risks.
    • Previous experience working within a quality-driven environment, ideally within the medical device, pharmaceutical, healthcare or other regulated industry.
    • Goods inn and customer returns Inspection.
    • Generating FAIRs and using company MRP system.
    • All using hand held devices such as Micrometers, Verniers, Thread…
    • Experience in system validation, testing or quality assurance within a medical device or regulated environment.
    • Strong analytical and problem-solving skills.
    • Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
    • The ideal candidate would be an aerospace graduate or a time service inspector.
    • They will consider experienced Inspectors who have previously worked within the…

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Job Post Details

Medical Device Auditor
London
£75,000 a year
Permanent

Job details

£75,000 a year
Cycle to work scheme
Permanent
London

Full job description

Medical Device Auditor - London / Remote We are partnering with our client to help them appoint a Medical Device Auditor. This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices. Key Skills & Experience
  • Medical Device Industry Experience (4+ years)
  • ISO 13485 QMS Auditing/Management
  • EU MDR / UK MDR for QMS
  • Software & SaMD Expertise desirable
Offered:
  • Up to £90,000 per annum
  • Share options
  • EV and cycle to work scheme
Interested? If you are looking to apply your quality expertise in a high-impact role within our client's team, please apply to this with your CV and we'll be in touch! To find out more about Computer Futures please visit www.computerfutures.com Computer Futures, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales
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