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Quality Manager

4 months ago

Northampton Northamptonshire, United Kingdom Michael Page Full time

Fantastic opportunity for a Quality Manager to join our medical device client in Northamptonshire on a 6 month Fixed Term Contract. Our client are a regulated manufacturing and distribution company based in the Northampton area. They are going through a period of growth and development and are currently looking for a Quality Manager to join their team on a 6 Month FTC. The role is suitable for someone looking for a step into management.

Creation and control of quality documents (SOPs, WIs, records etc)
Management Representative responsible for ISO 14385 certification and maintaining the effectiveness of the Full Support Healthcare QMS
Investigate and report on non-conformances, customer complaints and CAPA issues within specified timeframes
Validation of sterilisation and packaging processes
Arrange required product testing and review test reports
Validation of sterilisation and packaging processes
Completing QC inspections and checking samples as required
Monitoring of subcontracted processes including measurement and recording of environmental conditions significant to preservation of product and for packaging of product to be sterilised
5+ years' experience in a healthcare quality and regulatory compliance role.
Demonstrable technical writing capability.
Proven planning/organisational skills, ability to handle multiple projects simultaneously with the ability to meet tight timescales/deadlines. Knowledge and practical experience of using QMS software (Q-Pulse desirable).