Overview CPL are working with a leading Medical Equipment Manufacturing organisation with a growing workforce and expanding requirements for remote patient sampling, they require a Senior Quality Assurance Manager to join the team to achieve their ambitious growth in the coming years.
This position is based out of Croydon operating on a hybrid working model.
ResponsibilitiesResponsibility of the Management Representative for the ISO:13485 accreditationMaintain accreditations for ISO:13485, ISO: 9001, ISO:14001, ISO:27001, and FSCOversee the business' performance and activities to maintain GDP standards and maintain an MHRA WDA licenseCollaborate with the Senior Leadership Team to set quality benchmarks, the effectiveness of the quality management system and improvements requiredIdentify and review Quality issues, develop proposals, and make decisions with input from the QA teamPromote and approve processes and procedures in accordance with industry standards and customer expectations Competency requirementsStrong knowledge of ISO:13485, ISO:9001, ISO:27001Knowledge of GDP working practicesUnderstanding of and ability to determine relevance of governmental regulatory processes and regulations.5+ years of medical device industry experience, in Quality Assurance ManagementBroad knowledge of ISO 13485:2016, US FDA, and European Medical Device Regulations (MDD, MDR, IVDD, IVDR)Strong organization, communication, and problem-solving skills Apply Full name Email address Cover Message (optional) Upload CV Choose File Upload your CV and any other relevant file.
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