Senior QA Specialist

  • Salary: Competitive
  • REF Number: 00051991
  • Consultant: Sarah Farrow
  • Contact: 0191 3706486
  • Date Published: 22.10.2021
  • Sector: Diagnostics
  • Location: Camberley, Home Counties, South Coast, South East
  • Discipline: Qa / Validation

CK Group are recruiting for a Senior QA Specialist to join a leading developer of diagnostic devices, to be based at their site in Camberley on a permanent basis.

You will be responsible for assisting the Quality Manager in ensuring that all activities on site are in compliance with ISO13485 and ISO9001

Main duties and responsibilities

  • To ensure continued compliance of the QMS to ISO13485 and ISO9001, concerning all areas of the product life cycle from product development to discontinuation
  • Manage the maintenance, administration and execution of QMS processes through the use of SharePoint and/or Entropy. Monitor & report on KPIs.
  • Process owner for non-conformance & CAPA
  • Supporting and promoting the company document management systems, and equipment validation and maintenance processes.
  • Support product release process, including batch record review, generation of CoAs and uploading CoAs to website.
  • Use professional judgment in all areas of the role to make the appropriate quality decisions and to initiate and promote quality improvements to prevent re-occurrence
  • Collate data and prepare presentation for review with Quality Manager prior to Management Review, and assist with minuting review meetings.
  • Assist with external audits as required.

To be considered for the position you should have the following qualifications and experience:

  • Bachelor’s degree in Life Science.
  • Previous experience working in IVD manufacturing environment
  • ISO13485 Internal Auditor
  • Knowledge and experience of equipment software and process validation
  • Awareness of regulatory requirements. IVDD/IVDR

Experience of leading teams, and a background in microbiology would be beneficial for the role.

Entitlement to work in the UK is essential. For more information, or to apply for the role, please contact Sarah Farrow on 0191 3706486 or email sfarrow@ckgroup.co.uk. Please quote reference 51991 in all correspondence.

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