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Technical Quality Scientist

Location: Blackpool, Lancashire Salary: £30.00 - £33.00 per hour
Sector: Medical Devices Specialism:
Type: Contract Contact: Matt Henocq

Technical Quality Scientist

Summary:

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.

Role 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

Experience required:

  • 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.
We will contact you within the next 14 days if you are selected for interview. Privacy Policy. Equal Opportunity and Diversity Policy.

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