Sr. Quality Engineer
Current2005 - 2007: Quality Engineer responsible for process, equipment, and facility validations (IQ, OQ, PQ); creating documentation. CAPA, risk analysis, FMEA, Root Cause Failure Analysis for excimer lasers, intravascular catheters, fiber optics.2008-2009: Establish, plan, specify, instal, and operate an FA (failure analysis) and Material Science Lab for Spectranetics. Operate lab and perform failure analysis, technical support for R&D, Manufacturing, and Suppliers. Technical evaluation of… Show more 2005 - 2007: Quality Engineer responsible for process, equipment, and facility validations (IQ, OQ, PQ); creating documentation. CAPA, risk analysis, FMEA, Root Cause Failure Analysis for excimer lasers, intravascular catheters, fiber optics.2008-2009: Establish, plan, specify, instal, and operate an FA (failure analysis) and Material Science Lab for Spectranetics. Operate lab and perform failure analysis, technical support for R&D, Manufacturing, and Suppliers. Technical evaluation of customer returns.2010: Supervise FA & Material Science Lab. QE responsible for extrusion. Special project - QE resp. for catheter process improvement, implementing in-process SPC, risk management. Show less