ASQ-Certified Six Sigma Black Belt and Quality Engineer with ten years active Black Belt and Quality Engineering experience that includes: ISO 9001, 5S implementation, kaizen events, production and cash flow improvements. Additional experience includes Innovative Process (new product development) and assistance in manufacturing related root cause analysis and CAPA deployment. QFD, FMEA, DOE, and other six sigma tools in preparation for product launch. Most recently was responsible for and managed corrective actions related to regulatory commitments. Accomplishments:•Responsible for deploying and qualifying PCTs for the QA Ecosystem and achieving QA IMEx Certification in collaboration with QLT, PCT Leads, and QA Colleagues•Executed a segmentation analysis of the QA Ecosystem in a dynamic environment identifying ~18 potential PCTs to be deployed in two phases•Coached and developed 4 CI Specialists in for the QA Ecosystem who helped drive significant improvements in total open QARs (~85% decrease) and reduction in aged QARs (~113% improvement)•Executed and closed +20 CAPAs in response to regulatory agency audits with several requiring executing change control for successful implementation•Lead team responsible for more clearly defining maximum number of persons required in aseptic areas in response to several regulatory commitments•Maintained throughput and utilization goals through installation and validation of 2 new lyophilizers and several systemic and process changes while reducing a critical drug backorder by 97%. •Lead a lyophilization team that Increased lyophilization utilization throughput 113% from 2013 to 2014 increasing utilization by 6.7% exceeding stretch goal by 4.6% that closed 14 projects directly impacting lyophilization utilization and throughput.•Hoscar and Hospy Award Winner as most impactful team to transform the Hospira culture as co-leader of the Lyo Utilization Team•Directed team to increase throughput by 113% from 2013 to 2014 and reduced critical drug backorders by more than 80%•Make A Difference Award Winner as co-lead on Carpuject Continuous Improvement •Optimized spin weld process in a development project utilizing DOE (Design of Experiments) that reduced failure rates by +80%. •Conducted Capability Analyses (Cp/Cpk) to ensure production stability.•Facilitated System and Process FMEAs (Failure Modes and Effects Analysis) for +20 developmental projects.•Implemented FAI (First Article Inspection) process.•Yielded $823K in savings and cash flow projects as an in four facilities.