Jim Freeman
Senior Quality Assurance Manager at ICU Medical
- Role
- Senior Quality Assurance Manager at ICU Medical
- Location
- Antioch, IL, US
- LinkedIn followers
- 500 followers
About Jim Freeman
I’m a results-driven quality and design assurance leader with extensive experience guiding global teams in the medical device industry. I specialize in risk management, design assurance, and data-driven process improvement—turning analytics into actionable insight that strengthens compliance, improves efficiency, and drives measurable cost savings. Over my career, I’ve built and led high-performing teams at ICU Medical, Motorola, and BlackBerry, aligning quality initiatives with business strategy to deliver lasting operational impact. My work has included harmonizing global quality systems to meet EU MDR requirements, developing analytics tools that detect issues early, and spearheading initiatives that achieved multi-million-dollar savings. Colleagues know me for my cross-functional leadership, strategic mindset, and passion for solving complex problems at the intersection of engineering, data, and quality. I’m motivated by opportunities to elevate performance, empower teams, and ensure that medical technologies meet the highest standards of safety and reliability.
Experience
Senior Quality Assurance Manager
Jan 2014 — Present
As a Senior Manager of Quality Assurance, I drove global Quality System development and data analytics initiatives to significantly enhance compliance and operational efficiency across the enterprise. My focus was on transforming complex regulatory requirements into practical, compliant, and less complex processes.Key Contributions & Strategic Impact:• Global Regulatory Compliance: Successfully harmonized global Risk Management and Design Control processes specifically to meet stringent EU MDR requirements, ensuring international market access and compliance.• Data & Process Stewardship: Served as the analytics process steward, developing and implementing enterprise-wide metrics and dashboards. This included creating data tools and complaint dashboards that significantly enhanced early issue detection and drove targeted process improvement.• Operational Excellence: Led Kaizen events to optimize critical quality processes, including complaint management, field action, and change management. Additionally, optimized Agile PLM/Oracle workstreams to design-in more compliant and efficient system configurations.• Customer Quality Leadership: Functioned as the U.S. customer quality interface, directly driving improvements in customer satisfaction.
Education
Northwestern University
Masters of Engineering Management
University of Illinois Urbana-Champaign
BSEE
Skills
- Program Management
- Mobile Devices
- Failure Mode and Effects Analysis (Fmea)
- Product Development
- Fmea
- Six Sigma
- Product Management
- Integration
- Project Planning
- Management
- Process Improvement
- Quality Assurance
- Business Process Improvement
- Engineering Management
- Cross-Functional Team Leadership
- Continuous Improvement
- Defect Tracking
- Quality Management
- Wireless
- Engineering
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