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Quality Technical Scientist

  • Job reference: 929883
  • Location: Blackpool, Lancashire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 24/03/2020

Orion Group Sciences have an exciting opportunity for a Quality Technical Scientist for our Multinational Medical Devices client based in the Lancashire area on an initial 6-month contract.

Job Purpose

To deliver gap assessment and associated plan of action against applicable standards for EU MDR transition in line with submission for Class III devices.

Main Responsibilities of the role

  • 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
  • Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations
  • Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance

Desired Experience and Background of the successful candidate

  • Degree qualified - Science
  • Minimum of 2 years' experience in senior laboratory role
  • Previous experience in medical device or related regulated industry is essential
  • Previous experience of project management and leading of small projects
  • Knowledge of ISO and ASTM standards
  • Method Validation Experience
  • To have the ability of numerical reasoning, verbal reasoning and to be PC literate
  • Strong project management and problem-solving skills
  • Change Control and deviation experience. Desirable
  • Knowledge of specific ISO 5833, USP, JP, EP, BP
  • Working knowledge and experience in methodology for problem solving
  • ICH Guidelines (Q2 R1)
  • 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

    #medicaldevices #medical #device #13485 #multinational #product #implant #ISO #ASTM #MDR #validation #ICH #quality

For more information on this role, call Denise Cagney on +44 (0) 203 994 4695 or email for a completely confidential chat about this role and other opportunities using the reference number: 929883

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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