Primarily Customer Focussed

Major project - Focus on upgrading current quality system from component manufacturing to device manufacturing with FDA GMP / QSR Managed Quality Engineer and technician level activityCAPA's, Customer Complaints, Surveys, product testing and certification, supplier managementCoordinated activity of process engineers to resolve issues and improve quality systemManaged outsourced auditing programConducted management reviews to keep management team informedCoordinated… Show more Major project - Focus on upgrading current quality system from component manufacturing to device manufacturing with FDA GMP / QSR Managed Quality Engineer and technician level activityCAPA's, Customer Complaints, Surveys, product testing and certification, supplier managementCoordinated activity of process engineers to resolve issues and improve quality systemManaged outsourced auditing programConducted management reviews to keep management team informedCoordinated customer requests for BioCompatability testing working with NAMSA labsCertified Six Sigma Black Belt [change agent / project manager] 2003 - 2008The first several years were focused on cost-out projects with hard savings. The last year shifted to Enterprise Lean Sigma combining Six Sigma tools with Lean tools.Managed major continuous improvement projects with teams saving over $400,000 annually from 2004 through currentTaught and mentored 4 Green Belt waves (8-15 candidates in each wave)Facilitating ongoing Kaizen events (6) typically resulting in improved Value Stream MapsNew Plant layout & material flow (supply chain through production / shipping)Managing Daily Improvement (MDI) meetings implementation (addressing 25-30 issues/month) Coating Line Capacity Improvements (freed 75 days of needed capacity on constrained equipment)Lead projects with both critical customers and suppliers (transactional to cost out initiatives)Provided training at key customers on Six Sigma tools as well as quality toolsProblem Resolution K-T, FMEA, Process Maps, VSM Show less

Project management using six sigma tools. Mentoring and training other black belts and green belts.