Quality Assurance Specialist

2 weeks ago


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

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:
  • Hold a degree in a subject related to 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

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for Quality Assurance, we encourage you to apply for this exciting opportunity.



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