Medical Device Quality Assurance Specialist

3 days ago


Leeds, Leeds, United Kingdom Kinetica Full time

Job Overview

Kinetica is seeking an experienced quality assurance specialist to join our compliance team in West Yorkshire. As a key member of the team, you will be responsible for ensuring adherence to GMP and ISO 13485 standards.

The ideal candidate will have previous experience working within a quality role at a medical device company and a good understanding of ISO 13485.

Key Responsibilities

  • Document control and change control
  • NCR's, deviations, and customer complaint investigations
  • QMS maintenance and management
  • Root cause and CAPA
  • BATCH RELEASE (£50,000 - £65,000 per annum)
  • External auditing support
  • Validation (sterilisation, microbiology, and environmental monitoring)
  • Trend analysis and reporting
  • Updating, improving, and compiling SOP's
  • Internal auditing
  • Quality systems training
  • Leading quality improvement projects

Requirements

  • Previous experience working within a quality role at a medical device company
  • Experience in NCR's and CAPA
  • A good understanding of ISO 13485
  • Excellent attention to detail
  • Excellent communication skills


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