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 to ensure compliance with ISO 13485 standards.
  • 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 the quality and safety of our products.
  • Work closely with the Quality Assurance Manager to ensure the effective implementation of our QMS system.
  • Develop and maintain quality procedures and documentation to ensure compliance with regulatory requirements.

Requirements:

  • Relevant degree in a subject related to Quality Assurance, Quality Engineering, or Design Assurance.
  • Good understanding of Regulatory Affairs and ISO 13485 standards.
  • Experience in a Quality Assurance role, preferably in the Medical Devices industry.
  • Strong communication and interpersonal skills.
  • Ability to work independently and as part of a team.

What We Offer:

As a Quality Assurance Specialist at Newton Colmore Consulting Ltd, you will have the opportunity to work on a variety of projects and contribute to the development of our QMS system. You will also have the chance to work with a talented team of professionals and develop your skills and knowledge in the field of Quality Assurance.

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