Experience

SweetSpot Diabetes Care, Inc.

• United States
• Information Technology & Services
• 1 - 100 Employee

• Quality Engineer III Product / Software Development

  • Jan 2014 - Present



King System / Ambu Ltd.

• Indianapolis, Indiana Area

• Quality Engineer New Product Introduction

  • Aug 2012 - Jan 2014



ARA

• United States
• Defense and Space Manufacturing
• 700 & Above Employee

• Validation and Quality System Specialist

  • Mar 2010 - Aug 2012

  Provided quality and validation leadership in support of new product development and commercialization ensuring that the FIVR products and processes are of high quality and in compliance with applicable standards and regulations. Provided quality and validation leadership in support of new product development and commercialization ensuring that the FIVR products and processes are of high quality and in compliance with applicable standards and regulations.



HJ Heinz

• Process and Quality Technical Specialist

  • 2009 - 2011

  Provided leadership role in support of the development and deployment of Quality System process controls and continuous improvement activities to various process areas of manufacturing. Provided leadership role in support of the development and deployment of Quality System process controls and continuous improvement activities to various process areas of manufacturing.



Vistakon - Johnson&Johnson Vision Care

• Quality and Validation Engineer

  • Jan 1990 - Mar 2009

  Provided Quality Engineering leadership role in support of new product and process development activities including areas such as design control, risk management, quality system and testing (verification and validation). • Represented Quality Engineering during the product design and development phase to ensure quality deliverables (DHF, FMEA, Control Plans, DMR, product, process, equipment and test method validations) are in place prior to Design Transfer. Exercised the effective and efficient use of routine quality engineering techniques such as design control, risk management, validation protocols development, test method development, statistical data analysis, DOE’s, IQ/OQ/PQ, gage R&R studies and other quality engineering tools as required for cGMP regulated medical device manufacturing environment. • Led the testing (Verification and Validation) activities for new product, process, equipment and facilities. Generated Validation Master Plans and validation protocols (FAT, IQ, OQ PQ), performed risk analysis (design and process FMEA, Gap Analysis), prepared protocols and reports summary, and generated and executed test cases based on requirements. A total of 48 manufacturing lines on 2 different manufacturing platforms, both Jacksonville and Ireland facilities were successfully validated. Provided Process Engineering leadership role in support of the development and deployment of Quality System process controls and continuous improvement activities to various process areas of manufacturing. • Assisted manufacturing operations in problem solving to achieve cost effectiveness and improved process capabilities, yields and throughputs across manufacturing lines. Utilized extensive process knowledge and Six-Sigma methodologies (DMAIC, DMADV and DOE’s ) resulting in a proven and repeatable process as required for commercialization; and to determine root cause and implement effective solutions that reduce non-conformances Show less



NATIONAL SEMICONDUCTOR INC

• Senior Reliability / Failure Analysis Engineer

  • Sep 1983 - Jan 1990



National Semiconductor

• Semiconductor Manufacturing
• 400 - 500 Employee

• Quality Assurance Engineer

  • Sep 1983 - Jan 1990