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 jamie.keith@cpl.com.