Quality Assurance Officer

Quality Assurance Officer
  • £28,000 - £31,000 per Annum
  • Permanent
  • High Wycombe, Buckinghamshire, England, UK High Wycombe Buckinghamshire UK HP13 5AA
Job Ref: J2160766
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 03 September 2021
Leading Medical Device Maintenance and Supply Company - Lead EQMS Transition - Deputise for Leadership Team - Benefits and Progression

SRG partner with a fast-growing Medical Device Maintenance and Supply Company based in High Wycombe.

Reporting the Quality and Regulatory Affairs Manager, your experience in QA will enable you to lead audits, improve processes and deputise for the senior leadership team. Your expertise will enable you to lead the team through their EQMS transition.

Key Responsibilities:

  • Perform internal audits on ISO 9001:2015 and ISO 13485:2016 compliance at head office and occasionally at hospital sites across England
  • Report and manage non-conformances (CAPAs, deviations) and perform root cause analysis
  • Manage, update, create procedures (SOPs) and assist other departments in writing and revising procedures
  • Contribute to ensuring regulatory compliance
  • Deputise for the Quality Manager as and when required
  • Perform supplier audits and evaluations
  • Deal with customer complaints and customer feedback
  • Trend, analyse and report data for Management Review Meetings
  • Be instrumental in the implementation of an Electronic Quality Management System
  • Provide employee training on the quality management system, ISO standards and MHRA requirements


  • Experience in a Quality Assurance role, within a highly regulated industry: Medical Device, Pharmaceutical, Cosmetics or similar
  • Qualified Internal Auditor
  • Knowledge and understanding of ISO 9001:2015 Quality Management System Standard - ISO 13485:2016 desirable
  • Experience using, or implementing EQMS systems - transition from QMS
  • CAPA, Root Cause Analysis, SOP writing
  • Self-motivated, proactive and results driven
  • Strong problem solving skills, with high levels of attention to detail
  • Desire to learn, progress and provide innovation
  • Full UK Driving License


  • Work closely with the senior leadership team
  • Expert training and development plansPrivate Health Insurance
  • Death in Service Scheme
  • Pension Scheme
  • Onsite parking
  • 25 days holiday + bank holidays

03/10/2021 09:29:29
GBP 28000.00 31000.00 Annum
Contact Consultant:
Holly Evans

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