Quality Systems Program Manager

Medtronic•Minneapolis, MN

3d•$120,000 - $180,000•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. The Quality Systems Program Manager is responsible for leading the strategy, governance, and execution of key Quality System programs across the Twin Cities Campus manufacturing sites. This role partners closely with site Quality leadership and cross-functional stakeholders to ensure the effectiveness, consistency, and continuous improvement of the Quality Management System (QMS) in alignment with Medtronic standards and global regulatory requirements. The individual in this role will drive enterprise-aligned initiatives related to CAPA governance, audit strategy and execution, and regulatory inspection readiness, while fostering collaboration across manufacturing sites to strengthen quality culture and operational excellence. The Quality Systems Program Manager will use data-driven insights, strong program management capabilities, and cross-functional leadership to identify systemic opportunities, standardize processes, and ensure sustainable improvements across the campus quality system landscape. 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

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

Nice To Haves

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
Executive Reporting and Governance Forum Leadership

Responsibilities

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.