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Medical Device Quality Assurance Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

Job Summary

We are seeking a highly skilled Quality Assurance Engineer to join our team at Newton Colmore Consulting. As a Medical Devices Quality Engineer, you will play a critical role in ensuring the quality and safety of our medical devices.

Key Responsibilities:

  • Develop and implement quality assurance processes and procedures to meet ISO 13485 standards
  • Collaborate with cross-functional teams, including mechanical engineers, physicists, electronics engineers, and software engineers, to ensure quality and safety of medical devices
  • Create technical files and testing documentation to support quality assurance efforts
  • Conduct design assurance activities to ensure compliance with regulatory requirements
  • Participate in continuous improvement initiatives to enhance quality and efficiency

Requirements:

  • Bachelor's degree in a relevant field, such as engineering or a life science
  • Proven experience in quality assurance for medical devices, with knowledge of ISO 13485 and EN 60601 standards
  • Excellent communication and collaboration skills, with ability to work effectively in a team environment
  • Strong analytical and problem-solving skills, with ability to identify and resolve quality issues

What We Offer:

  • Competitive salary and bonus structure
  • Generous pension and benefits package
  • Opportunities for professional growth and development