Quality Systems Coordinator

Quality Systems Coordinator

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 :

• 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.

Qualifications :

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.

The University of Minnesota offers a comprehensive benefits package that includes 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.

How To Apply :

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section. To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.