Michele Fusello-Gardill
MBA, CQE, Global Medical Devices Quality & Compliance Leader
- Role
- Global Capa Transformation Quality Manager at Olympus Corporation
- Location
- West Chester, PA, US
- LinkedIn followers
- 500 followers
About Michele Fusello-Gardill
I am a Quality and Compliance leader with a broad range of experience in the medical device industry. I make data-driven and patient-focused decisions to solve complex issues and produce practical and sustainable solutions. I communicate effectively across levels and functions and I am passionate about professional development and continuous learning.
Experience
Global Capa Transformation Quality Manager
Mar 2024 — Present
Leading the design and continuous improvement of a state-of-the-art global CAPA and NC process and system. Integrating cross-functional processes to expedite escalations and investigations using a risk-based and patient-centered approach. Running cross-functional workshops and debrief sessions for leadership and stakeholders to coordinate inputs from more than 50 Quality Management Systems across over 100 sites. Supporting organizational change management, business case development, and project planning. Collaborating on strategies for global process transition, training deployment, and KPI management.
Education
Drexel University's LeBow College of Business
Master of Business Administration (MBA), Business Analytics
West Chester University of Pennsylvania
Bachelor of Science (B.S.), Industrial Mathematics
Skills
- Fda
- Six Sigma
- Process Improvement
- Statistical Data Analysis
- Medical Devices
- Capa
- Quality System
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