Trained and certified as a CAPA leader for Abbott to manage CAPA Investigations and Resolutions.
Lead multidisciplinary teams in investigations into deficiencies elevated to the level requiring a CAPA.
Closed CAPAs in a timely manner with monitoring plans to verify efficacy of prescribed corrective action.
Participated in several CAPAs as SME for mechanical development and testing.
Notable investigations include electrode damage in Aveir and blade dullness for Confirm Rx
Developed new tests and performed testing to characterize the extent of the issues to assist in the determination of root cause and monitoring of corrective action.