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Quality Assurance and Regulatory Affairs Assistant

2 months ago

Bethesda, Gwynedd, United Kingdom Westcott Search Full time

Role:
Quality Assurance and Regulatory Affairs Assistant

Salary:
Extremely competitive basic salary plus annual bonus

Location:
Bethesda, Bangor


Our client, a leading global Medical Device company, is currently seeking a Quality Assurance and Regulatory Affairs Assistant to join their team.


This is a fantastic opportunity to join an extremely successful and forward-thinking company, for an experienced individual who is eager to develop their career.


Reporting to the QA/RA Manager, this job role is to support the Quality and Regulatory Team by assisting with policies on quality standards and regulatory compliance; and assisting with the execution of the Quality Team duties.


Essential Job Functions

  • Inspecting, verifying and maintaining compliance documentation including responsibility for the document control system.
  • Supporting the design and maintenance of the Quality System
  • Maintaining supplier, distributor, and customer communications and records
  • Complying with all safety policies, practices and procedures
  • Supporting the monitoring and measuring activities, including NCRs, CAPAs, and Customer Complaints
  • Key participant within the QA/RA team in the execution of their duties.
  • Risk Management Team Member
  • Assist with the review of documentation

Qualifications:

  • Previous experience in QA/RA
  • Strong attention to detail
  • Proficient in Microsoft packages
  • ISO 9001 experience
  • EU, UK medical device regulation training an advantage, but not essential.

Job Types:
Full-time, Permanent

Benefits:

  • Company pension
  • Onsite parking

Schedule:

  • Monday to Friday

Supplemental pay types:

  • Performance bonus
  • Yearly bonus

Experience:

  • Quality assurance: 1 year (required)

Work Location:
In person