Quality Systems Program Manager
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-07-13
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-13
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
- 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
- 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
- Quality Management Systems
- CAPA Program Leadership
- Root Cause Analysis
- Regulatory Compliance
- Audit Strategy
- KPI Development
- Data-Driven Decision Making
- Quality System Process Standardization
- Operational Excellence
- Continuous Improvement
- Cross-Functional Leadership
- Collaboration
- Governance
- Communication
- Strategic Planning
- Problem Solving
- Stakeholder Engagement
- Performance Monitoring Risk Management
- Facilitation
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