- CAPA system design, management and closure
- Regulatory deficiency FDA 483 and warning letter response
- Field complaint and product reliability issues
- Interim functional leadership
Led core team for FDA warning letter response at medical device manufacturer. Improved quality system procedures, validated out-of-compliance processes, and laid groundwork to re-validate common processes across multiple product lines.
Results: Passed FDA follow-up audit with no observations.
Served as interim director of engineering and operations for small medical device manufacturer/distributor after incumbent’s unplanned departure. Led and coached staff while improving processes. Developed optimal departmental structure and filled open positions, including new director.
Results: Met all annual operating plan goals.