John Toporek Email & Phone Number

Ann Arbor, Michigan

Experience in Validation - Instrument/Operations (software and hardware) and Process Qualifications, writing Design Validation Protocols/Completion Reports, and internal Audit Discrepancy Report Problem Resolution. Responsibilities also include Reliability Life Testing (Highly Accelerated Life and Stress) of cardiovascular bypass medical devices - Central Control Monitors and controlled laboratory testing of Advanced System 1 operations equipment, power supplies.electro-mechanical equipment, blood temperature control monitors and blood circulation devices in a bio-hazard contained environment.Experience in sterilized product validation - cannulae ink banding processes in a clean room environment. Recent Engineering Change Control duties include updating Risk Management and Hazard Analysis reference documents.Provided support for recalls including internal notifications and CAPA determinations.Product Development lead in maintaining all calibrated test equipment.

Powertrain Quality Analyst specializing in cost, repair andthings-gone-wrong warranty improvement/customer satisfaction forFreestar, Monterey, Mustang, Escape and Mariner vehicle lines. Highexperience in early identification of customer concerns, root causeanalysis, problem resolution and communication of action plans toaffected engineering and plant management teams.Recognized by Powertain Engineering Director for populating BalancedSingle Agenda for Quality with quality improvement action projects toestablish roadmaps to meet objectives for 2008 and 2009 model yearquality targets while department staff reductions from 6 employees in2003 to 1.5 per vehicle line by 2006.Lead a cross-functional powertrain quality team to resolve spark plugfouling, coolant hose leak concerns and early automatic transmissionfailures on the 2006 and 2007 model year Escape/Mariner.Provided weekly quality data support to the Plant Vehicle Team at AutoAlliance Plant to improve plant engine and transmission assembly keyquality processes. Key contributor to early detection, root causeanalysis and fix implementation of 2005 model year Slow Fuel Fill andMalfunction Indicator Lamp/Evaporative Emission Leak powertrain launchconcerns on Mustang.Achieved all powertrain quality objectives of things-gone-wrong for2004 model year Freestar/Monterey Best in Ford Company Quality.