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 interested then please send your CV to [email protected]