Quality Assurance Specialist

1 week 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 and implementation of our 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 to ensure compliance with ISO 13485 standards.
  • Work closely with the manufacturing teams to ensure quality and regulatory compliance.
  • Develop and maintain quality procedures and documentation.
Requirements:
  • Relevant degree in a subject related to Quality Assurance, Quality Engineering, or Design Assurance.
  • Experience in Quality Assurance, Quality Engineering, or Design Assurance, preferably in the Medical Devices sector.
  • Good understanding of Regulatory Affairs and ISO 13485 standards.
  • Excellent communication and teamwork skills.
What We Offer:
  • Opportunity to work with a growing Medical Devices company based in Cambridge.
  • Chance to develop and implement a QMS system for ISO 13485 standards.
  • Collaborative and dynamic work environment.
  • Competitive salary and benefits package.

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