Responsible for Internal and External Manufacturing Quality for DePuy Synthes as well as Direct and Indirect Suppliers globally.

Serves as a member of the Vogue International Leadership team with responsibility for all aspects of Quality Assurance & Compliance for the Vogue business. Responsible for integrating the newly acquired Vogue International business into the Johnson & Johnson family of companies.

Responsible for all Johnson & Johnson Vision Care (JJVC) Quality and Regulatory Compliance worldwide including complaint management compliance.*Implemented full Quality Management System (QMS) in 45 Johnson & Johnson Vision Care (JJVC) Market Companies worldwide. Partnered with cross functional and cross sector teams to implement quality system components in the Market Companies.*Ensures the QMS complies with external regulatory requirements such as FDA, ISO, GDP, Health Authority regulations (by Country), as well as internal Johnson & Johnson Enterprise and JJVC Franchise requirements. This includes all distribution centers, warehouses and third party logistic operations in the Market Companies affiliated with JJVC.*Manages senior level management team of Q&RC professionals worldwide.*Responsible for internal, ERC and outside Health Authority audit compliance in the Market Companies.*Responsible for complaint handling and techno vigilance worldwide. Implemented regional call centers outside the US to drive compliance in complaint handling and adverse event reporting.*Partners with Regulatory Affairs, Medical Affairs, Supply Chain, to ensure quality and regulatory compliance across the globe.

Responsible for Product Quality of 6 brands within Vision Care’s product portfolio. *Proactively monitor, analyze and improve all aspects of product quality for the end use customer to drive the total customer experience.*Partnered with R&D and Supply Chain/Operations and Quality Engineering to ensure both legacy and new products are robust and adhere to all critical to quality elements.*Managed two major Franchise quality initiatives to improve the overall customer experience. Led a cross functional team in order to identify root cause and implement novel solutions.

Managed and oversaw 16 production lines in a high speed, dynamic, FDA regulated, continuous operations medical device manufacturing environment. The facility produces over 400MM units a year for ten different products and 9,000+ SKUs. *Managed seven new product introductions from R&D experimentation to IQ/OQ/PQ on the manufacturing floor.*Managed and forecasted operations controllable budgets totaling $20MM annually. *Managed department operation schedule and strategic planning for all manufacturing lines.*Managed department Change Control, CAPA, RCI process.*Personally coached, trained and mentored seven salaried Engineer direct reports and their 152 subordinate wage personnel. *Led a department wide First Off Quality improvement project with a 2.0% overall decrease in FOQ rejects.

Responsible for production, quality, safety and CREDO in a 24/7 manufacturing operation of 16 production lines in a high speed, dynamic manufacturing environment. Championed and mentored employees in their Greenbelt certification process.*Department CREDO scores up an average of 16% in 2006 over 2005.*Nightshift CREDO scores up an average of 30% in 2006 over 2005.*Led 3rd Generation Manufacturing Operations compliance initiative in 2006. Coordinated training and established systems to comply keep organization in compliance. Zero non-conformances in Regulatory Audit, BSI Audit, Environmental Audit, SGOP Assessment, and PSM Keyhole Assessment in 2006.*Production increased 23% in 2006 over 2005.*Quality increased 2% in 2006 over 2005.*Budget favorable $6.1MM; lens cost favorable 2 cents over Business Plan in 2006.*Managed Human Resource nightshift to dayshift technician migration consistently and fairly.

Process Engineering owner for several brands and manufacturing lines. Led multiple projects to increase throughput and output, increase yield, decrease scrap and decrease quality defects. •Led new product qualification for Acuvue Advance for Astigmatism through IQ/OQ/PQ. Product was qualified 4 months early. •Certified as Six Sigma Blackbelt. Project savings of over $30k per month in reduced quality defects. •Certified as Six Sigma Greenbelt. Reduced in process debris related defects by 90%.•Qualified existing products on new manufacturing platforms for capital avoidance.

Process Engineering owner for a variety of products and divisions within 3M. Responsibilities include but not limited to; pilot plant scale up to manufacturing, maintaining integrity of equipment, running statistically designed experiments, improving rates and yields, statistical process control methods, documentation, capital improvements, etc.*Start up of an R&D pilot plant facility in MN for a new technology platform for film making. 3M Six Sigma Greenbelt certified. Team leader for five Six Sigma projects with a combined annualized savings of over $2MM. *Partnering with R&D and Operations Manufacturing, successfully scaled up pilot plant technology to an operations plant in Greenville, SC. *Manufacturing improvement initiatives for yield, cost savings, and labor savings.