Quality Systems Specialist
About The Position
As a Quality Systems Specialist, you will play a vital role in maintaining and enhancing the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal standards. Your expertise will support audit activities, CAPA documentation, and reporting processes, contributing to the overall success of the organization's quality initiatives at the Rice Creek Pharma Operations Manufacturing site in Fridley, MN. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Requirements
- Bachelor's degree with 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0+ years of work experience in Quality or regulated industry
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- Organize audit backrooms, prepare documentation, and facilitate communication between auditors and teams.
- Assist CAPA owners with documentation, ensure process compliance, and monitor timelines.
- Create and deliver accurate QMS reports to support quality initiatives and improvements.
- Hands-on experience with QMS platforms such as TrackWise.
Responsibilities
- Provide oversight for the 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.
- Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Lead 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 (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.
- Co-ordinate legal requests in support of government investigations or litigations.
- Ensure the quality assurance programs and policies are maintained and modified regularly.
- Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
