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Medtronic’s Neuromodulation/Pelvic Health organization is hiring a Quality Systems Specialist to join their onsite team in Fridley, Minnesota. This will be a hybrid role that will require at least 3 days onsite.

A Day in the Life
In this exciting role, you will have responsibility for working with Corrective and Preventive Actions (CAPA) owners and quality issue/nonconformance owners across the Neuromodulation/Pelvic Health organization to execute the CAPA process in a compliant and timely manner.
Responsibilities may include but are not limited to:
Collaborate on development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Participate in audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
Prepare reports and/or necessary documentation (i.e., CAPA) and provide to applicable stakeholders, both internal and external.
Assist in legal requests in support of government investigations or litigations.
Ensure the quality assurance programs and policies are maintained and modified regularly.
Work closely with issue identifiers and owners to assess whether new product or quality system issues will escalate to CAPA investigation.
Guide CAPA owners through CAPA phases and ensure they follow the CAPA process and deliver solid quality records of their actions.