Quality Assurance Specialist

1 day ago


Eden Prairie, Minnesota, United States UnitedHealth Group Full time

About the Role
At UnitedHealth Group, we are dedicated to helping people live healthier lives and making the healthcare system work better for everyone. As a Quality Assurance Specialist, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and safety.

Key Responsibilities

  • Maintain a fit-for-purpose Quality Management System (QMS) aligned with applicable medical device regulations and industry standards.
  • Analyze upcoming changes in relevant regulations, standards, and corporate processes to ensure compliance.
  • Administer electronic QMS software to support quality management activities.
  • Develop and deploy training on QMS, standards, best practices, and electronic QMS software.
  • Conduct internal quality audits and ensure timely completion of corrective actions.
  • Collaborate with cross-functional teams to promote a culture of quality and safety.

Requirements

  • 7+ years of experience in the medical device industry.
  • Hands-on experience in authoring processes and maintaining a QMS.
  • Proven knowledge of FDA Quality System Regulation (QSR) and ISO 13485:2016.
  • Excellent attention to detail, verbal, and written communication skills.

Compensation

The estimated salary for this role is $120,000 per year, commensurate with qualifications and experience.



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