Senior QA/RA Officer

Job Title: Senior QA/RA Officer
Contract Type: Permanent
Location: Newcastle upon Tyne, England
Salary: £30000 - £35000 per annum
Start Date: 2019-09-11
Reference: BH-109926-2
Contact Name: Gregory Robertson
Contact Email:
Job Published: September 12, 2019 14:40

Job Description

Senior QA/RA Officer – Newcastle – Permanent 

My client, a multinational biotechnology company in Newcastle is currently seeking the expertise of a Senior QA/RA officer to maintain and improve their quality management system by identifying potential improvements, developing, revising and implementing quality procedures and policies.

Senior QA/RA Officer Key Responsibilities:
  • Compiling and maintaining technical files, medical device files and device master records in preparation for regulatory submissions
  • Take an active role in product risk management processes.
  • Take an active role in software development by ensuring compliance with ISO 62304 is maintained
  • Design review and control of change processes during product development.
  • Help train staff in Quality and Regulatory requirements, leading training sessions when necessary.
  • You will administer, prepare, conduct and report internal quality system audits and external vendor assurance audits.
  • Assist in the implementation of systems that facilitate productivity, improve processes and guarantee efficiency
  • Maintain the company’s electronic QMS, Q-Pulse, including monitoring and progression of CAPA and audit actions
Senior QA/RA Officer Key Requirements:

  • Educated to a degree standard in a relevant scientific of engineering-based subject.
  • Experience working to ISO 13485 and ISO 14971.
  • Previous experience working within quality assurance
  • Ability to communicate effectively with multiple departments and to represent the company in external audits.
  • Experience conducting Quality and Regulatory Affairs training programmes.

This permanent vacancy for a Senior QA/RA officer is a fantastic opportunity to join a highly innovative multinational company. All candidates must be eligible to work full-time in the UK without restrictions. If you have the necessary criteria outlined above then please apply without delay.