Senior Quality Assurance Manager

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.

Responsibilities Responsibility of the Management Representative for the ISO:13485 accreditation Maintain accreditations for ISO:13485, ISO: 9001, ISO:14001, ISO:27001, and FSC Oversee the business' performance and activities to maintain GDP standards and maintain an MHRA WDA license Collaborate with the Senior Leadership Team to set quality benchmarks, the effectiveness of the quality management system and improvements required Identify and review Quality issues, develop proposals, and make decisions with input from the QA team Promote and approve processes and procedures in accordance with industry standards and customer expectations Competency requirements Strong knowledge of ISO:13485, ISO:9001, ISO:27001 Knowledge of GDP working practices Understanding of and ability to determine relevance of governmental regulatory processes and regulations.
5+ years of medical device industry experience, in Quality Assurance Management Broad knowledge of ISO 13485:2016, US FDA, and European Medical Device Regulations (MDD, MDR, IVDD, IVDR) Strong organization, communication, and problem-solving skills If you are interested please apply or send your CV to