|Location: Blackpool, Lancashire||Salary: £30.00 - £33.00 per hour|
|Sector: Medical Devices||Specialism:|
|Type: Contract||Contact: Matt Henocq|
Technical Quality Scientist
To deliver gap assessment and associated plan of action against applicable standards for EU MDR transition in line with submission for Class III devices.
Duties and Responsibilities:
- To conduct and lead gap assessments against applicable standards
- Develop action plans for closure of gaps identified.
- Present updates to relevant stakeholders
- Write technical justifications to provide evidence that test methods/processes/procedures meet MDR requirements.
- Co-ordinate own week to week workload in line with your project plans and departmental priorities and overall business framework. Collate resource hours.
- Develop intimate 'hands-on' knowledge of core business products
- Develop technical expertise in raw materials, in-process products and finished products testing.
- Review of laboratory validation documentation.
- Adhere to the Change Control and Design Control requirements.
- Laboratory experience and knowledge
- Experience of working with combination products (Device - Drug)
- Responsible for applying effective problem solving techniques and tools to resolve product performance issues
- To promote and improve technical knowledge and support in meeting the strategic needs of the business
- Minimum of 2 years experience in a senior lab role
- Previous experience in medical device or related regulatory industry is essential
- Knowledge of ISO and ASTM standards
- Method Validation experience
- To have the ability of nummerical reasoning, verbal reasoning
- Change Control and deviation experience
Services advertised by Gold Group are those of an Agency and/or an Employment Business.