Experience

U.S. Leadership, Inc

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Consultant

  • Jun 2016 - Present



St. Jude Medical

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• • Sep 2010 - Jun 2016

  Specialties: Working knowledge of Lean Manufacturing / 6-Sigma principles, Process Validation, Statistical Analysis, ANOVA, Data Trending / Interpretation, Process Characterization. Development, implementation and improvement of Quality Systems (cGMP, 21 CFR part 820 / ISO 13485).Leadership Skills: Mentor, Trainer, Project Manager

• • May 2004 - Sep 2010

  -Led Quality Engineering Team- identified innovative ways to build team’s strength, worth and confidence. -Supervised Quality Inspectors across several production lines (for incoming inspection, in-process inspection and final product release). -Managed companywide system for control of nonconforming material. -Subject Matter Expert for internal and external audits (FDA, TUV and Corporate Audits).-Served as Quality Engineering lead for several Manufacturing operations that included -Cardiovascular and Neuromodulation devices. -Managed test laboratory- coordinated and scheduled product testing. -Companywide SAP lead trainer for Quality modules. -Led several Lean/Six-Sigma projects and initiatives to continuously improve manufacturing yields, reduce product costs, improve quality and service levels. Show less



Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Engineer

  • Sep 1997 - Mar 2004

  -Quality Engineering Lead for several production lines. -Company-wide multi-disciplinary trainer on Quality tool deployment (i.e. Lean Six Sigma) and organizational behavioral (i.e.diversity training, re-defining company core values). -Led Lean/Six-Sigma projects and initiatives to continuously improve manufacturing yields, reduce product costs, improve quality and service levels. -Core team member for next generation Endovascular device. -Quality Engineering Lead for product and process transfer between sites (Florida, Mexico and California). -Santa Rosa Site Team Lead for the harmonization and integration of the Risk Management process within the business units (Galway-Ireland, Santa Rosa-Ca, and Danvers-Massachusetts). Show less