JOSEPH ELLINGHAUS

Strategic Process Improvement Manager with experience in technical, regulated businesses. Expertise in FDA 21 CFR / EU / China GB, ISO9001, ISO13485, and DLA (U.S. Army) QMS-regulated environments. Skilled in collaborating across organizations and cultures with international colleagues, customers, and suppliers. Passionate about optimizing product and business processes through technology enablement.

• Implemented online, real-time process monitoring and controls for complex continuous flow production of photo-voltaic panels. Performed analysis of production data to identify key process input variables and projected optimal settings to maximize power output. Team increased power output from 45W to 75W.
• Designed architecture and led development of enterprise data system for automated reporting of product performance at Fortune 500 computer manufacturers. Reduced labor for support of most complex customer by 96% while substantially expanding reporting and analysis capabilities. Co-chaired multi-year effort with limited IT resources as Six Sigma Black Belt projects.
• Developed and implemented enterprise data system for managing and reporting customer issues and escalations
• Developed data analysis and reporting tools to provide product and customer performance reports on a weekly basis, as well as special analyses as requested by executive management. Improved turn-around time for special requests from a few days to a few hoursManaged customer concerns and escalations by providing compelling insights gained from complex field return data analysis and correcting identified root causes. Measured remedial actions to minimize ultimate impact to OEM customers and their customers. In one case, narrowed customer concern from a few hundred thousand units to less than two thousand units with a failure signature that the customer could easily manage.
• Combined field failure data with data from a DOE I designed to assess and manage shipped product and inventory reliability to protect customer satisfaction.
• Merged field return data with supply-chain and manufacturing traceability data to identify specific component, supplier, and lots causing an uptick in customer returns.
• Implemented data system to monitor and report complete supply chain, manufacturing, and test of lot controlled chemical / biological / nuclear weapons resistant hydration reservoir system supplied to the U.S. Army.

ISO 13485:2016 (Medical Device, MD) Certified Internal Auditor Training February 2021

DEKRA

Certified Biomedical Auditor May 2014 to June 2017

Certified Reliability Engineer October 1986 to September 1992

ASQ

Lean Six Sigma Master Black Belt 2010

Villanova University

Six Sigma Green Belt / Brown Belt 2000 / 2007

Design for Six Sigma 2007

Design for Reliability 2008

Seagate US LLC

Magnetic Susceptibility Studies of Laccase and Oxyhemocyanin, D. Dooley, R. Scott, J. Ellinghaus, E. Solomon, and H. Gray, Proc. Natl. Acad. Sci. USA, Vol. 75, No. 7