Quality Systems Coordinator

University of Minnesota•Minneapolis, MN

64d•$36 - $41•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.
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.

Benefits

Competitive wages, paid holidays, and generous time off
Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
Low-cost medical, dental, pharmacy and disability plans
Healthcare and dependent care flexible spending accounts
University HSA contributions
Employer-paid life insurance
Employee wellbeing program
Excellent retirement plans with employer contribution
Public Service Loan Forgiveness (PSLF) opportunity
Financial counseling services
Employee Assistance Program with eight sessions of counseling at no cost
Employee Transit Pass with free or reduced rates in the Twin Cities metro area