Senior Quality Systems Administrator

2 weeks ago


Cambridge, Cambridgeshire, United Kingdom https:jobs-redefined.cositemap Full time

Job Title: Senior Quality Systems Administrator (Maternity Cover)

Contract: Full-time

Contract Type: 12 month's fixed term contract.

Location: Cambridge Science Park

Hybrid: Two days on site

Responsible to: Senior QA Compliance Officer

Endomag is a global technology company that believes everyone deserves a better standard of cancer care. Our team has helped over 500,000 women around the world access more precise and less invasive breast cancer care.

Key Responsibilities:

  • Electronic ISO 13485 quality system maintenance, configuration, and implementation of new processes, and validation activities.
  • Documentation control to ensure implementation of changes to procedures within the QMS and technical files as standards evolve.
  • Managing quality procedures across supply chain partners and manufacturers to ensure maintenance of standards.
  • Quality audit actions completion in a timely manner.
  • Maintenance of documentation for future products related to quality assurance processes and maintain records for compliance and auditing purposes.
  • Release process for new product release to customers, logging and maintenance of repairs and complaints and associated tasks.
  • Support the QA Director and QA/RA Compliance Manager during audits by Notified Body or other organisations as required.

Requirements:

  • Previous experience of configuring eQMS systems or systems platforms within a pharmaceutical or Medical Device environment.
  • Experience with pharmaceutical or medical device Quality administration is advantageous.
  • Degree or equivalent in computing/engineering/Life Science or closely related field.
  • 1-5 years' experience in ISO quality systems for pharmaceutical or, ideally, medical devices.
  • Good IT skills (MS Office) are required.
  • Experience with validation of software platforms is desirable but training will be given.

Willingness to occasionally travel within the UK.



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