Quality Management Officer

Location UK / Belfast

Job Type Temporary part-time

Salary Not disclosed

Updated 1 week ago

Reference 1435903

 Job Description

Excellent opportunity for a Quality Management Officer based in Belfast

Job Advert – Quality Management Officer

We are now recruiting a Quality Management Officer who will be a key member of our team.

Temporary (potential to become permanent)

Key Responsibilities

  • ensuring all documents associated with the company’s Quality Management System (QMS) are consistently reviewed and updated
  • ensuring compliance with regulations set by the Medicines and Healthcare Regulatory Agency (MHRA) for the company’s existing portfolio of in vitro diagnostic products
  • preparing regulatory submissions for any new products or extensions of existing ones
  • planning and overseeing all internal/external audits
  • keeping up to date with changes in regulatory legislation and guidelines
  • outlining requirements for labelling, storage and packaging
  • reading and understanding scientific and legal documents
  • organising and collating information in a variety of formats
  • maintaining familiarity with company product portfolio and pipeline

Skills & experience

  • Previous experience in maintaining a QMS in a diagnostics/medical device company
  • Previous experience of the CE Mark registration process
  • Ability to understand and summarise clinical data
  • Previous involvement in internal/external audits
  • “Small company mindset”, with willingness to seek innovative solutions to challenges
  • Eligibility to work in the UK

To apply please click the APPLY NOW button below and your send cv outlining how you meet the criteria

For further information about the company, please visit www.proaxsis.com

No recruitment agencies please.  ProAxsis is committed to responding to all applicants, including those not selected for interview, but due to the high number of applications we receive for job openings, there may be a time delay for this.