Fantastic opportunity for a Quality Manager to join our medical device client in Northamptonshire on a 6 month Fixed Term Contract. Applicants should be experienced with ISO 13485, validation and verification and MDR would be advantageous.
Client Details
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.
Description
Key Responsibilities but not limited to:
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
Maintenance and communication where required of technical documentation
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
Notified / Approved Body Audits & other External Audits
Manage Internal audit programme
Monitoring of subcontracted processes including measurement and recording of environmental conditions significant to preservation of product and for packaging of produ...