Business Unit Leader
Arrow International
Jan 2000 - Jan 2007 (7 years 1 month)
-Coordinating Planning, Production, and Maintenance activities for all 3 shifts of catheters manual assembly and injection molding areas.
-Directwork priorities and time-lines and allocate resources to assure overall goals (SQDC) are meet and time-lines achieved.
-Prepareand review Catheters Business unit budget and lead cost and efficiency improvement.
-Knowledgeof ISO 13485, GMP's, FDA, OSHA regulations.
-CleanRoom environment handle ISO 7 (100,000 class).
-Knowledgeof TUV and FDA regulations and audits.
-Validations,Qualifications, start ups and tryouts of new products.
-Knowledgeof FMEA, Root Cause Analysis, and control plans.