Quality Assurance Specialist

2 days ago


Eden Prairie, Minnesota, United States UnitedHealth Group Full time
Job Overview

At UnitedHealth Group, we are committed to helping people live healthier lives and making the health system work better for everyone. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our medical devices and contributing to our mission.

Key Responsibilities
  • Maintain a fit-for-purpose Quality Management System in line with applicable medical device regulations and industry standards
  • Observe and impact analyze upcoming changes in relevant regulations, standards, guidance, and corporate processes
  • Administer electronic Quality Management software supporting the management of the Quality Management System
Requirements
  • 7+ years of experience in the medical device industry
  • Hands-on experience in authoring processes and maintaining a Quality Management System
  • Proven knowledge of FDA Quality System Regulation (QSR) and international standard ISO 13485:2016
Estimated Salary Range

$88,000 - $173,200 annually based on location and experience

Benefits include a comprehensive benefits package, incentive and recognition programs, equity stock purchase, and 401(k) contribution. We are an equal opportunity employer and welcome applications from diverse candidates.



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