Quality Assurance Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

Job Summary

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 Quality Management System (QMS) for ISO 13485 standards.

Key Responsibilities

  • Assist in the development and implementation of our QMS system
  • Create and manage technical files for Medical Devices lines, including Class I, Class IIa, and Class IIb devices
  • Collaborate with Medical Devices experts to ensure compliance with ISO 13485 standards
  • Work closely with the Quality Assurance Manager to ensure seamless quality assurance processes
  • Develop and maintain quality procedures and documentation

Requirements

  • Hold a degree in a relevant field, such as Quality Assurance, Quality Engineering, or Design Assurance
  • Have a good understanding of Regulatory Affairs
  • Have experience working in a Quality Assurance role, preferably in the Medical Devices sector
  • Be able to work independently and as part of a team
  • Have excellent communication and problem-solving skills

What We Offer

  • A competitive salary and benefits package
  • The opportunity to work with a leading recruitment agency in the Medical Devices sector
  • A dynamic and supportive work environment
  • Professional development opportunities

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