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Medical Device Quality Coordinator

Surrey   •  Permanent, Full time


Jim Gleeson is recruiting for a Medical Device Quality Coordinator to join a pharmaceutical company preparing to launch their first product. This will be a fully office based position in Guildford.
Salary: Around £35K plus good benefits
RESPONSIBILITIES:
As Medical Device Quality Coordinator you will be responsible for supporting the management and performance of operational quality processes.
Key duties will include:

  • Ensuring full compliance to Medical Device SOPs and Pharma SOPs relevant to role
  • Working with the Head of Quality and Quality Manager to ensure procedures and systems are maintained or established to maintain the Company?s compliance with ISO 13485 and to enable the manufacture of medical devices in accordance with current national and international legislation, relevant regulations, standards and guidelines
  • Responsibility for co-ordinating periodic training and familiarisation processes in accordance with the MD Training and Familiarisation Matrix
  • Providing support for inspections by regulatory bodies; notified bodies; customers; and independent associates
  • Responsibility for maintaining the CAPA Register, tracking actions to completion, providing regular updates regarding CAPA completion to the Head of Quality and Quality Manager and retaining the completed CAPA Forms

QUALIFICATIONS:
As Medical Device Quality Coordinator you will require:

  • A relevant life science degree
  • Industry based medical device QA experience
  • Good knowledge and experience of Quality Management Systems, e.g. ISO 13485, ISO 9001, GCP, GMP, GDP and the EU and UK Medical Devices Regulations
  • Successful experience of being inspected by MHRA/Notified bodies
  • Knowledge of software systems (EDC, CTMS, eTMF, IXRS) is advantageous

Apply:
Entitlement to work in the country you are based in is essential. For more information please contact Jim Gleeson on 01438 842973 or email jgleeson@ckclinical.co.uk. Please quote reference 51831 in all correspondence.


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Jim Gleeson
  • Phone: 01438 743 047
  • Reference: 51831
  • Posted: 6th October 2021
  • Expires: 3rd November 2021

CK Group

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