Experience

Quest Global Engineering Services GmbH

• Germany
• Engineering Services
• 100 - 200 Employee

• Supplier Remedition /Quality Engineer

  • Oct 2021 - Present

  Assess supplier capabilities through direct on-site visits and technical discussions. Communicate manufacturing requirements and issues to supplier(s). Identify, prioritize, and resolve manufacturing issues with supplier(s). Work with supplier(s) and internal customers to identify necessary improvements and report progress on those improvements Assess supplier capabilities through direct on-site visits and technical discussions. Communicate manufacturing requirements and issues to supplier(s). Identify, prioritize, and resolve manufacturing issues with supplier(s). Work with supplier(s) and internal customers to identify necessary improvements and report progress on those improvements



Phillips-Medisize

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

• Quality Engineer

  • Oct 2020 - Aug 2021

  • Support implementation of new software identifying and resolving issues as projects move through the quality system. • Create process maps, work instructions as required. • Collaborate with project engineers. • Support other divisions with the same newly created processes. • Support implementation of new software identifying and resolving issues as projects move through the quality system. • Create process maps, work instructions as required. • Collaborate with project engineers. • Support other divisions with the same newly created processes.



Torax Medical, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Sn. Supplier Quality Engineer

  • Jul 2019 - Jul 2020

  • Support of New Product Development and ongoing manufacturing activities internally and with external suppliers. • Provide supplier issue resolution • Manage interactions with suppliers domestic and international. • Validations, IQ, OQ, PQ., Supplier Non-Conformances, CAPA’s. • Perform supplier audits. • Evaluate and recommend changes to the Quality system changes to facilitate the integration of Torax into the Ethicon quality system. • Support of New Product Development and ongoing manufacturing activities internally and with external suppliers. • Provide supplier issue resolution • Manage interactions with suppliers domestic and international. • Validations, IQ, OQ, PQ., Supplier Non-Conformances, CAPA’s. • Perform supplier audits. • Evaluate and recommend changes to the Quality system changes to facilitate the integration of Torax into the Ethicon quality system.



Imperial Plastics, Inc

• United States
• Plastics Manufacturing
• 1 - 100 Employee

• Sn. Quality Engineer | Quality Systems Engineer

  • Mar 2018 - Jun 2019

  • Responsible for and manage the daily activities of 13 quality staff of inspectors, receiving inspection, and programmers (CMM, SmartScope). • Interface with customers and generate all documents related to PPAP’s, FAIR’s, 8D’s. • Lead all customer requested and internal audits • Manage internal and external corrective action activities • Statistical review of product data for issues, trends and improvements as needed • Provide and evaluate current inspection equipment and recommend cost effective equipment upgrades or replacements. • Collaborate with multiple groups across all levels of the company to rewrite the QMS in preparation for and transition audit for ISO 9001:2015



Ameritek International

• Industrial Machinery Manufacturing
• 1 - 100 Employee

• Supplier Quality Manager

  • Sep 2016 - Aug 2017

  • Modified quality management system compliant with ISO 9001. • Implemented supplier performance risk management methodology, monitoring supplier performance. • Implemented CAPA system. • Implemented supplier performance metrics and corrective action system. • Implemented supplier process verification and validation protocols. • Modified quality management system compliant with ISO 9001. • Implemented supplier performance risk management methodology, monitoring supplier performance. • Implemented CAPA system. • Implemented supplier performance metrics and corrective action system. • Implemented supplier process verification and validation protocols.



3M

• Germany
• Chemical Manufacturing
• 1 - 100 Employee

• Senior Supplier Quality Engineer (Contract)

  • May 2016 - Sep 2016

  • Collaboratively develop a supplier quality department supporting of all 3M health care divisions using GHTF recommendations as a foundation. • Work with 3M manufacturing plants to develop, align, and implement new SQE protocols including supplier corrective actions, supplier corrective actions, MSA requirements, GD&T, etc. • Work with suppliers to implement the new protocols across all health care divisions.. • Collaboratively develop a supplier quality department supporting of all 3M health care divisions using GHTF recommendations as a foundation. • Work with 3M manufacturing plants to develop, align, and implement new SQE protocols including supplier corrective actions, supplier corrective actions, MSA requirements, GD&T, etc. • Work with suppliers to implement the new protocols across all health care divisions..



Uponor

• Finland
• Wholesale Building Materials
• 700 & Above Employee

• Supplier Development Engineer (Contract)

  • Feb 2016 - Apr 2016

  • Partnered with supplier to improve performance, including validation protocols. • Resolved past due and current 40 corrective actions. • Performed organizational audit on supplier. • Performed process audit on supplier. • Partnered with supplier to improve performance, including validation protocols. • Resolved past due and current 40 corrective actions. • Performed organizational audit on supplier. • Performed process audit on supplier.



Horton, Inc.

• United States
• Transportation/Trucking/Railroad
• 100 - 200 Employee

• Corporate Quality Engineer

  • Mar 2014 - Nov 2015

  • ISO/TS16949 ISO representative. • Interim quality manager for manufacturing plant is S. Dakota for 5 months. • Assisted in developing the supplier quality management system and the supplier manual. • Implemented customer complaint system. • Implemented material review board. • Modified CAPA program to be compliant with ISO/TS requirements. • Rewrote procedures to meet ISO/TS compliance requirements. • Internal auditor for ISO/TS 16949 and ISO 14001. • Worked with current suppliers to improve quality and performance. • Performed external audits on supply base. • Approved prospective suppliers through extensive auditing process. • Developed internal and supplier process validation protocols.



Nelson Numeric

• United States
• Aviation and Aerospace Component Manufacturing
• 1 - 100 Employee

• Director Of Quality

  • Oct 2012 - Jun 2013

  Manufacture of machined aerospace components. • Managed 10 quality staff. • Modified the established quality management system certified to ISO 9001-2008 and AS9100. • Established procedures compliant to ITAR requirements. • Established supplier quality management system, including the generation of a supplier manual. • Introduced the use of SPC and other sigma tools to manufacture aerospace components. • Reduced percentage of returned components from an annual rate of 3.8% to 0.15%. • Justified and purchased data collection software.



Custom Mold & Design

• United States
• Plastics Manufacturing
• 1 - 100 Employee

• Coporate Quality Manager

  • Jun 2008 - Sep 2012

  • Established quality management system, achieving and maintaining certifications for ISO 9001 & AS 9100. • Established and maintained ITAR compliance. • Justified and purchased capital equipment (data collection software, CMM). • Established quality management system, achieving and maintaining certifications for ISO 9001 & AS 9100. • Established and maintained ITAR compliance. • Justified and purchased capital equipment (data collection software, CMM).



Teamvantage Molding-Injection molding and assemblies for the medical devise and aerospace industries

• Corporate Quality Manager

  • Nov 2007 - Sep 2012

  • Managed 16 quality staff and 2 warehouse shipping and receiving staff. • Established quality management system certified to ISO 9001, AS 9100, and ISO 13485. • Established and maintained ITAR compliance. • Established a supplier quality management system, including the generation of a supplier manual. • Introduced the use of SPC and other Six Sigma tools into use for mold and process analysis, including IQ, OQ, PQ, and process validation. • Justified and purchased capital equipment (data collection software, CMM, and OGP Smartscope). • Improved rate of customer returns from 4% to 0.002%.



Boston Scientific - medical device manufacture

• Supplier Quality Engineer

  • Feb 2007 - Sep 2007

  • Assessed suppliers’ manufacturing and acceptance criteria against FDA requirements.. • Resolved supplier manufacturing issues related to component quality and manufacturing processes, using Six Sigma tools, five S and lean approach. • Recommend modifications to improve the supplier manufacturing and inspection system. • Assessed suppliers’ manufacturing and acceptance criteria against FDA requirements.. • Resolved supplier manufacturing issues related to component quality and manufacturing processes, using Six Sigma tools, five S and lean approach. • Recommend modifications to improve the supplier manufacturing and inspection system.

• Supplier Development Enginner

  • 2003 - 2007

  • Co-authored supplier quality department procedures in compliant to domestic and international regulatory requirements. • Assisted suppliers in the development of quality systems, including achieving multiple quality and industry certifications. • Identified deficits and created paths of improvement for suppliers working with all levels within the supplier’s organization. • Partnered with suppliers to resolve issues related to component quality, manufacturing efficiencies, and on-time delivery using Six Sigma tools. • Performed process and organizational audits of supplier systems and methods. • Developed test methods to determine component and assembly performance acceptability. • Participated in new product development teams identifying appropriate suppliers in addition to defining performance requirements, evaluating manufacturing, and inspection methods.