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Quality Systems Coordinator
Quality Systems CoordinatorUniversity of Minnesota • Twin Cities
Quality Systems Coordinator

Quality Systems Coordinator

University of Minnesota • Twin Cities
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

About the Job

The Quality Systems Coordinator provides auditing and reporting support for Quality Systems, and development assistance in ZenQMS. The person in this position needs to be detail oriented, be an independent decision maker, and find and seek solutions to basic technical or operational problems.

This position is based out of Minneapolis, MN and is eligible for hybrid work from home and / or on campus work dependent upon individual performance and organizational need, though some regular on-site work will be expected. Because the University of Minnesota is a land-grant institution that serves the state, residing in Minnesota is typically required.

Job Responsibilities :

30% :

  • Assist with development and implementation of ZenQMS (quality management system electronic solutions) for Quality Systems.
  • Assist with creation of electronic technical training opportunities in ZenQMS.

70% :

  • Utilize the supply tracking system, BTM. Investigate and approve new vendors of controlled supplies. Approve new product categories in BTM. Approve controlled supplies in BTM prior to release for use.
  • Request and track receipt of final autopsies for applicable donor cases; forward autopsies for donor eligibility review and track the completion of the review.
  • Perform assigned internal audits of core Food and Drug Administration (FDA) and Eye Bank Association of America (EBAA) functions (facilities, environmental monitoring, equipment, supplies and reagents, tissue labeling, recovery, processing, evaluation, storage, distribution and donor eligibility determination). Prepare all audit documentation including the final report and corrective actions.
  • Work with technical managers to identify opportunity for preventive actions, plan, monitor and report on recurrence.
  • Participate in project and change management.
  • Track the consignee of tissue to ensure all required information is received.
  • Create and send human tissue recipient follow up reports for transplanting surgeons, review incoming reports, and alert quality systems manager to adverse events; participate in adverse event investigations potentially related to transplant product.
  • Assist in investigation of FDA and EBAA deviation and recall based on audit and review findings.
  • Assist with FDA and EBAA inspection processes as needed.
  • Assist with documentation preparation for EBAA accreditation.

    • Qualifications

    All required qualifications must be documented on application materials.

    Required Qualifications :

  • BA / BS with at least 2 years of experience or a combination of related education and work experience to equal six years.

    • Preferred Qualifications :

  • Patient or donor records review and auditing experience to include release / approval of records based off established health criteria.
  • Facility records auditing experience.
  • Tissue or organ donation industry experience.

    • About the Department

    The Department of Ophthalmology and Visual Neurosciences and its success is built upon the innovation and drive of every member of our team, from faculty to administrators to technicians. Put simply, all of us are driven to provide the best eye care for our patients, discover new treatments, and educate the next generation of eye care professionals.

    For more information please visit our website at

    Lions Gift of Sight (formerly Minnesota Lions Eye Bank) was established after the partnership between the Lions and the Department of Ophthalmology & Visual Neurosciences came to life in 1960, providing donor eye tissue for transplant, research, and teaching and promoting donation through education. Lions Gift of Sight has helped restore sight to more than 22,000 people by providing cornea tissue for transplantation and is one of the largest and most successful eye banks in the world.

    For more information, please visit our website at :

    Pay and Benefits

    Pay Range : $36.43 to $41.32 per hour, we anticipate most offers will be around the midpoint of this range, depending on education and experience.

    Time Appointment : 100% Appointment

    Position Type :   Civil-Service

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