Quality Assurance Specialist

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time
Job Title: Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Assurance Specialist, you will play a crucial role in the development of our QMS system for ISO 13485 standards.

Key Responsibilities:

  • Assist in the development of the QMS system for ISO 13485 standards
  • Create and manage technical files for Medical Devices lines, including Class I, Class IIa, and Class IIb Medical Devices
  • Collaborate with Medical Devices experts and receive Quality Assurance assistance from the parent company's Quality Assurance Manager
  • Develop and implement Quality Assurance procedures and processes
  • Conduct audits and inspections to ensure compliance with ISO 13485 standards

Requirements:

  • Relevant degree in a subject related to Quality Assurance, Quality Engineering, or Design Assurance
  • Good understanding of Regulatory Affairs
  • Experience in Quality Assurance, Quality Engineering, or Design Assurance
  • Ability to work in a team environment and communicate effectively

What We Offer:

  • Opportunity to work with a growing Medical Devices company
  • Chance to develop and implement Quality Assurance procedures and processes
  • Collaborative and dynamic work environment

For more information, please contact Andrew Welsh, Director of Medical Devices recruitment, Science recruitment, and Biotech recruitment specialists Newton Colmore Consulting Ltd.

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