Quality Systems Program Manager

Medtronic

Quality Systems Program Manager coordinating quality initiatives across manufacturing sites at Medtronic. Overseeing compliance, audits, and continuous quality improvements in regulated environments.

Posted 5/15/2026full-timeMinneapolis • Minnesota • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $180,000 per yearWebsite

About the role

Key responsibilities & impact

Drive the overall strategy and execution of Quality Systems across the Twin Cities Campus manufacturing sites, ensuring alignment with Medtronic global quality standards, regulatory requirements, and business objectives
Partner with site Quality leadership and cross-functional stakeholders to develop and implement a quality systems roadmap that strengthens compliance, operational effectiveness, and continuous improvement
Provide governance and oversight for the Corrective and Preventive Action (CAPA) program across the campus, ensuring timely investigation, effective root cause analysis, appropriate corrective actions, and sustainable systemic improvements
Monitor CAPA performance metrics, identify systemic trends, and drive cross-site actions to improve quality system effectiveness and reduce recurrence of issues
Lead the development and execution of site audit strategies, including internal audits, external audits, and regulatory inspection readiness across the Twin Cities Campus
Coordinate audit planning, preparation, and follow-up activities to ensure sites maintain a constant state of regulatory readiness and address audit observations effectively
Serve as the Site Coordinator for two Case for Quality participant sites, ensuring conduct of effective appraisals and leading site-level implementation of improvement initiatives
Facilitate cross-site collaboration to share best practices, standardize quality system processes, and drive consistency across manufacturing locations
Develop and track key quality system performance indicators and provide regular updates to site and enterprise leadership on program status, risks, and improvement opportunities
Lead cross-functional governance forums related to quality systems performance, CAPA oversight, audit outcomes, and continuous improvement initiatives

Requirements

What you’ll need

Requires a Bachelor’s Degree with 5+ years of work experience in Quality and/or experience in a regulated industry
OR Advanced Degree with 3+ years of work experience in Quality and/or experience in a regulated industry
Quality Management Systems (QMS) Strategy, Governance, and Continuous Improvement
CAPA Program Leadership, Root Cause Analysis, and Systemic Issue Resolution
Regulatory Compliance (FDA, Global Regulations) and Inspection Readiness
Internal, External, and Regulatory Audit Strategy and Execution
Enterprise Program Management for Multi-Site Quality Initiatives
Quality Metrics, KPI Development, and Data-Driven Decision Making
Cross-Functional Leadership Across Quality, Manufacturing, and Operations
Quality System Process Standardization and Best Practice Implementation
Operational Excellence and Continuous Improvement in Regulated Manufacturing

Benefits

Comp & perks

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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management SystemsCAPA Program LeadershipRoot Cause AnalysisRegulatory ComplianceAudit StrategyKPI DevelopmentData-Driven Decision MakingQuality System Process StandardizationOperational ExcellenceContinuous Improvement

Soft Skills

Cross-Functional LeadershipCollaborationGovernanceCommunicationStrategic PlanningProblem SolvingStakeholder EngagementPerformance MonitoringRisk ManagementFacilitation