Medical Devices Quality Engineer

1 week ago


Oxford, Oxfordshire, 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 Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities

  • Develop and implement quality management systems to meet ISO 13485 standards
  • Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics Engineers, and Software Engineers
  • Conduct risk management and internal audits to ensure compliance with regulatory requirements
  • Validate medical devices and implement corrective actions as needed
  • Work closely with the Quality Assurance Manager to develop and implement quality policies and procedures

Requirements

  • Relevant degree in a field such as Medical Devices, Biotechnology, or a related field
  • Experience in quality assurance and regulatory compliance in the medical devices industry
  • Knowledge of ISO 13485 standards and 21 CFR Part 820
  • Excellent communication and problem-solving skills

What We Offer

  • A competitive salary and benefits package
  • The opportunity to work with a dynamic and growing company
  • A chance to make a real impact in the medical devices industry


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