Quality Assurance Specialist

2 months ago

Great Abington, United Kingdom Cure Talent Full time

Cure Talent are delighted to be partnered with an exciting Diagnostics company, specialising in GI Cancer, who, due to their continued growth, have an exciting opportunity for a QARA Specialist to join them.


Have you got what it takes to succeed The following information should be read carefully by all candidates.

As the new QARA Specialist, you will work closely with the QA & RA Managers to develop and manage the existing QMS and work closely on the implementation and transition to an eQMS. Alongside this you will be heavily involved in CAPA & NCR processes, SOP creation, auditing and RA support.

We are looking for an experienced Quality Assurance professional with a proven background in In Vitro Diagnostics or Medical Devices. You will have strong experience in the management and/or implementation of an ISO 13485 QMS, CAPA processes and auditing.

Key Responsibilities:

  • Develop and Maintain ISO 13485 QMS
  • Support the implementation and transition to an eQMS
  • Creation and implementation of SOPs
  • CAPA Process
  • Auditing
  • Support RA with Risk Management, Clinical Study Documents and Technical Files

Qualifications:

  • Degree educated in a relevant scientific or technical field
  • Proven experience in the IVD or Medical Device Industries
  • Proven experience in the maintenance and/or implementation of an ISO 13485 QMS
  • Proven experience and knowledge of CAPA Process and Auditing
  • Auditing certification is highly advantageous

If you have the necessary skills and experience to be successful in this role, please get in touch with the team at Cure Talent today

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