Quality Assurance

• Aug 2021 - Present

Regulatory and Quality Assurance Manager

• May 2019 - Jul 2021

Director, Packaging Development

• May 2018 - Mar 2019

• Collaborate with Marketing, R&D, and Regulatory Affairs to design and produce new products.• Propose and oversee cost savings projects reducing COGS.• Locate and qualify contract manufacturers.• Support design transfer to manufacturing.• Design and implement efficient supply chain for high and low volume products.

Director, Quality Management Systems

• Mar 2012 - May 2018

• Design, configure and validate eQMS System to meet specific organizational needs.• Manage team to gather requirements and configure system.• Develop and execute manual and automated test scripts for system validation.• Develop and publish documentation for user training and conducted training.• Manage Document Control, Complaints Handing and Product inspections teams.• Lead FDA site inspections, and other third-party audits of the quality system.• Improve quality processes for Non-Conformance Reports, inspection, returns, document management and others.• Advise colleagues in regional offices on design of local quality systems.

Manager, Global Quality Management Systems

• Aug 2009 - Mar 2012

• Direct supervisor of Document Control functions including SOPs, specifications, training records, and related systems.• Collaborate with process owners to ensure the documentation matches current practice.• Continuous improvement of the Nu Skin quality systems.• Manage internal audit process.• Developed and deployed database to manage SOPs.• Maintained training database.• Scripted daily reports in MS Excel from SAP, MS Access and oracle databases.

Quality Engineer

• Aug 2006 - Aug 2009

• Develop, improve and implement inspection methodologies for new and existing products.• Audit suppliers to ensure conformance to cGMP and Nu Skin standards.• Collaborate with cross functional teams to evaluate root cause and implement solutions to resolve issues.

Packaging/Production Engineer

• Aug 2005 - Aug 2006

• Collaborate with a cross functional development team to create new products and maintain vitality in existing products.• Manage specifications and costs for a range of products.• Develop, source and test packaging for new product initiatives.

Project Engineer

• Jul 2002 - Aug 2005

• Source, purchase and install equipment to increase plant capacity, capability and efficiency.• Coordinate production of new products, working with suppliers, customer and internal functions to ensure project success.• Monitor and work with Operations to improve production line efficiencies. • Source, purchase and install equipment to increase plant capacity, capability and efficiency.• Coordinate production of new products, working with suppliers, customer and internal functions to ensure project success.• Monitor and work with Operations to improve production line efficiencies.

Machinist

• Jan 1997 - May 2002

• Operate engine lathe, milling machine and other machine tools to repair or fabricate new parts used in chemistry labs.• Design and build, and make to print work. • Operate engine lathe, milling machine and other machine tools to repair or fabricate new parts used in chemistry labs.• Design and build, and make to print work.

Foundry Man

• Sep 1991 - Jun 1994

• Mold making, rubber two piece molds in plaster shell, ceramic investment molds on wax• Bronze casting, divestment and finishing including welding, grinding polishing• Design and build facility support equipment • Mold making, rubber two piece molds in plaster shell, ceramic investment molds on wax• Bronze casting, divestment and finishing including welding, grinding polishing• Design and build facility support equipment