Compliance Management during FDA Investigation
- Contributed to a major year-long effort to restructure a manufacturing site
- Revised manufacturing and maintenance practices and documentation
- Actively participated in the key audits
Quality Control Optimization
- Analyzed current QC processes
- Analyzed risks vs. benefits of each operation
- Rationalized the resources needed for an effective Quality Control process without increasing quality risk
Lead Time Reduction
- Analyzed WIP and Cycle Times
- Revised process flow
- Reduced lead times via Lean Management
