- NPD within the IVD arena, with an established, growing organisation
- Innovate across QMS system, assisting with EQMS transition
- Leeds based role with remote working options
SRG partner with an intuitive immunotherapies developer, who operate in the IVD arena as one of their central arms. Due to continual business growth, and in anticipation of further product indications, your expertise as a Quality Assurance Specialist is required to ensure their system is ISO 13485 compliant.
- Supporting the management of the electronic quality management software system, including the management of quality management system documentation
- Managing quality records to prevent damage or deterioration and provide ease of access
- Manage the co-ordination and investigation of non-conformance as part of the non- conformity and CAPA system, including implementations of corrective and preventive actions
- Manage customer complaints as part of the non-conformity and CAPA process.
- Reporting to the Head of Quality and Regulatory on the effectiveness of the quality management system and any need for improvement, including preparing and circulating the monthly quality progress report, supporting to create quality data and trends required of Management Review/Management updates and general meetings.
- Support change control and new product development by providing expertise to ensure that quality requirements are achieved.
- Supporting the management of the internal and external audit program including implementation of corrective actions.
- Supporting calibration and maintenance equipment activities.
- Reviewing supplier qualification documentation as part of the supplier evaluation and monitoring process.
- Ensuring that all work is completed to a high standard within specified time frames and an accurate record of all work is maintained.
- Providing training relating to the quality and regulatory system to all levels of staff within the business as applicable.
- Liaise with the manufacturing team to co-ordinate and support production activities in compliance with quality standards.
- Support manufacturing team to ensure all raw materials are correctly managed, product documentation is completed and approved and product release procedures are currently completed.
- Degree educated, or equivalent in Chemistry/Biological Sciences/Life Sciences
- Experience working with Quality Management Systems, within the IDV or Medical Device arena Similarly regulated industries will be considered: Pharma, Food, Medical Supplies
- Demonstrable working knowledge and experience of working within a ISO13485 framework or similar
- Experience with Validation activities within the scope of ISO13485
For more information, or to discuss your career in the Quality Assurance/Regulatory Affairs arena, please contact Holly Evans on email@example.com
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