Quality Systems Manager

Quality Systems Manager
  • £50,000 - £60,000 per Annum
  • Permanent
  • Cambridge, Cambridgeshire, England, UK Cambridge Cambridgeshire UK SG8 6ED
Job Ref: J2162614
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 11 November 2021
QSM Lead Role, with a thriving IVD organisation. Cambridge based, some flex working. Join at the forefront of a well funded start up.

Ambitious, well-funded point of care molecular diagnostics business, with an impressive growth plan. Part of a larger group, they offer the fluidity of an innovative start up, teamed with fantastic benefits: 12% pension, Bonus, Private Medical, Life Insurance.

As Quality Systems Manager, you will be responsible for ongoing maintenance and innovation across their EQMS system.


  • Ensuring system regulatory compliance for the company's emerging IVD device initiatives
  • Act as the Official Correspondent and liaise with Auditing Organisations, Notified Bodies and Regulatory Authorities
  • Report on key performance measures for quality improvements and compliance
  • Ensure the awareness of, compliance to, regulatory (ISO 13485, 21 CFR Part 820/ QSR, IVDR) and customer requirements throughout the organisation
  • Ownership of the CAPA, Change and quality event systems
  • Own the Quality training programme and undertake quality and compliance training
  • Be the subject matter expert relative to applicable international standards and regulatory requirements


  • Experience of Quality Management, Quality Assurance or Quality Systems leadership in the medical devices or IVDs industry
  • Proven track record of managing positive interactions with Auditing Organisations, Notified Bodies and Competent Authorities, in addition to ensuring that standards of communication and correspondence with regulatory bodies are maintained and documented
  • Proven experience of process, procedure and quality system development and maintenance
  • Thorough understanding of the latest versions of applicable medical device standards including ISO 13485, 14971 and FDA Quality System Regulations (QSR)
  • Experience with electronic quality system software as System Administrator
  • Previous experience with Dot Compliance QMS software a plus

11/12/2021 10:54:39
GBP 50000.00 60000.00 Annum
Contact Consultant:
Holly Evans

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