As a Quality Manager, you will be responsible for site specific aspects of the Quality Management System.
Your main duties as a Quality Manager will be to:
- Manage the requirements for the quality and regulatory compliance for the design, manufacture, sale and global distribution of products.
- Manage QA and QC team.
- Support for regulatory and customer audits.
- Provide quality and Regulatory support to the development and OEM project, including the generation, review and approval of process validation documentation.
- Review and approval of technical, regulatory and QMS documentation.
- At least five years' experience as Quality Manager in a diagnostic environment.
- Fully conversant with the key regulations for in vitro diagnostic devices, IVDD, IVDR.
- Experienced and conversant with current requirements for ISO 9001, ISO13485 and 21 CFR Part 820.
- Qualified internal auditor.
- Knowledge of molecular diagnostics, qPCR technology and applications.
For more information or to apply for this Quality Manager position, please contact CK Technical on or email , quoting job ref 48268.
It is essential that applicants hold entitlement to work in the UK.
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