Michelle Dionisio
Regulatory Affairs Professional
- Role
- Regulatory Affairs Supervisor at Abbott
- Location
- Colorado Springs, CO, US
- LinkedIn followers
- 500 followers
About Michelle Dionisio
Experienced medical device leader. Skilled in global labeling regulatory requirements, advertising and promotional material, ISO, FDA, TUV, project management, people management, Microsoft Suite, process validation/qualification, quality systems, GMP, supplier management, post market surveillance, and complaint management. BS focused in Industrial and Systems Engineering.
Experience
Regulatory Affairs Supervisor
Sep 2022 — Present
Education
Northern Illinois University
BS, Industrial and Systems Engineering
2004 — 2009
Skills
- Value Stream Mapping
- Process Improvement
- Engineering
- Microsoft Word
- Industrial Engineering
- 21 Cfr Part 11
- Medical Devices
- Capa
- Corrective and Preventive Action (Capa)
- 5s
- Complaint Investigations
- Quality Assurance
- Continuous Improvement
- Iso
- Fda
- Validation
- Project Management
- Powerpoint
- Microsoft Excel
- Dmaic
- Sap
- Kaizen
- Non-Conformances
- Quality Management
- Microsoft Powerpoint
- Iso 13485
- Quality Engineering
- Mdr
- Quality System
- Quality Systems
- Lean Manufacturing
- Data Analysis
- Six Sigma
- Quality Auditing
- Fmea
- Quality Control
- Gmp
- Software Documentation
- Root Cause Analysis
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