Senior Quality Systems Administrator
2 weeks ago
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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