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Vacancy – Office-Based Quality Assurance


21st July 2021

CVs, applications, and any queries related to the any of vacancies below should be sent to [email protected]. Alternatively, you can apply via our recruitment form. Please state which role you are applying for in the subject line or at the top of your message.

 

All roles come with the following benefits package:

  • 25 days paid holiday per year + statutory
  • Pension scheme
  • Private Health Insurance
  • Death in Service Scheme

 

Quality Assurance and Regulatory Affairs Officer

Salary:  £26,000 – £31,000

Full time, permanent basis.  Monday – Friday. 8:30 – 5pm.  To start ASAP.

The role will be based at our HQ in High Wycombe, HP13 5SH, reporting to the Quality and Regulatory Affairs Manager. Experience in the medical device industry or another highly regulated industry, such as pharmaceuticals, is desirable.

 

Key Responsibilities:

  • Perform internal audits on ISO 9001:2015 and ISO 13485:2016 compliance at head office and occasionally at hospital sites across England
  • Become a quality subject matter expert
  • 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
  • Perform supplier audits
  • Deal with customer complaints and customer feedback
  • Perform supplier evaluations
  • 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
  • Drive continuous improvement

Required:

  • Experience in a Quality Assurance role for 2+ years
  • Knowledge and understanding of ISO 9001:2015 Quality Management System Standard
  • A desire to learn and progress
  • High level of attention to detail
  • Self-Motivated and results driven, able to work on your own initiative
  • Proficient in the use of Microsoft Excel, Word and ideally also familiar with Visio
  • Good problem-solving skills
  • Ability to manage own workload
  • Full UK Driving license
  • Excellent report writing skills
  • Excellent communication and interpersonal skills, an active listener
  • Excellent command of the English Language
  • Experienced in root cause analysis
  • Highly organised

The Ideal Candidate:

  • Qualified internal auditor
  • Knowledge and understanding of ISO 13485:2016 Medical Device Quality Management Systems Standard
  • Experienced in the use of an electronic quality management system
  • Familiar with ISO 17025
  • Good understanding of European and UK Medical Device regulations

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