Quality Assurance Manager

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

  • Develop and implement QMS processes and procedures to ensure compliance with ISO 13485 standards
  • Collaborate with cross-functional teams to identify and mitigate quality risks
  • Conduct audits and inspections to ensure adherence to QMS standards
  • Manage and maintain technical files for Medical Devices, including Class I, Class IIa, and Class IIb devices
  • Provide quality assurance assistance to the manufacturing teams

Requirements

  • Bachelor's degree in a relevant field, such as Quality Assurance, Quality Engineering, or Design Assurance
  • Proven experience in Quality Assurance, preferably in the Medical Devices industry
  • Knowledge of ISO 13485 standards and QMS principles
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team

What We Offer

  • A dynamic and supportive work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package


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