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Medical Device Quality Manager

Surrey   •  Permanent, Full time

Jim Gleeson is recruiting for a Medical Device Quality Manager to join a pharmaceutical company preparing to launch their first product. This will be a fully office based position in Surrey.
Salary: Around £56,000 per annum plus good benefits
As Medical Device Quality Manager you will report to the Head of Quality and be responsible for 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
  • Ensuring that 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
  • Undertaking the formal Management Representative role and have day to day responsibility for running the MD QMS
  • Involvement in the management of inspections by regulatory bodies in support of the company\'s accreditations, as well as those performed by customers and independent associates
  • Responsibility for drawing up Internal and External Audit Plans (including the design of audit / inspection programs as necessary)

As Medical Device Quality Manager you will require:

  • A relevant life science degree
  • Extensive 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
  • Good project management skills and capability to work with a small team of people

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 51832 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: 51832
  • Posted: 6th October 2021
  • Expires: 3rd November 2021

CK Group

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