Technical Quality Scientist

Location: Blackpool, Lancashire Salary: £30.00 - £33.00 per hour
Sector: Medical Devices Type: Contract
Contact: Matt Henocq Job Published: 15 days ago

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.

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

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