- Process and procedure streamlining
- Leadership and technical mentoring
- Continuous improvement deployment: Six Sigma, Lean, DRM
- Best practice incorporation: Guidelines, checklists and templates
In response to internal audit findings, overhauled design control procedures, ensuring requirements were directly traceable to applicable regulations, efficient to implement, and incorporated best practices through guidance documents and templates.
Results: Addressed all deficiencies and passed subsequent FDA audit.
Coached cross-organizational team tasked with introducing design and manufacturing process improvements to significantly reduce field complaints across multiple geographies while balancing complex regulatory and supply chain considerations.
Results: Reduced field failure rates by 50% concurrent with significant improvement in first-pass yield.