Lead Auditor (Medical Device) - Birmingham

  • Salary: £30,000 - £35,000
  • REF Number: 00045231
  • Consultant: Naynesh Mistry
  • Contact: 01246 457700
  • Date Published: 09.04.2019
  • Sector: Pharmaceutical, Medical Devices, Life Sciences, Healthcare, Diagnostics
  • Location: West Midlands
  • Discipline: Technical Sales/Support, Research And Development, Qa/Validation, Microbiology, Biotechnology, Biochemistry

Naynesh Mistry has an exciting opportunity and is recruiting for a Lead Auditor/ Quality Audit Specialist to join a leading specialised medical diagnostic company based in Birmingham on a permanent basis. Our client engages in the research, development, manufacture, and distribution of immunodiagnostic assays for the laboratory market.

The Role: To conduct internal and supplier audits as Lead Auditor to meet regulatory requirements and follow up to ensure any deficiencies are appropriately addressed i.e. NCRs (Non-Conformance Report) and CAPAs.


  • Ensure all audit NCRs are fed through the NCR system as appropriate.
  • To represent the company where required at external audits.
  • Quality System Advisor.


  • Biological or chemical based degree or equivalent.
  • Qualified Lead Auditor.
  • Training in FDA Quality System Requirements.
  • Full understanding of ISO13485/IVD Directive/ FDA QSR.
  • CAPA Management.
  • Working within a manufacturing environment.
  • Audit planning, execution and follow-up.


  • Process and equipment validation training attended.
  • Japanese Ordinance 69/ISO9001, Health Canada.
  • Experience of research and development of biological and chemical based products.
  • Knowledge of antibody/ antigen reactions.

To apply for this position contact Naynesh Mistry on 01246 457703 or email nmistry@ckscience.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45231 in all correspondence.

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