Medical Device Manufacturing Excellence Summit

LINNETTE TORRES is the chief quality officer at Integra LifeSciences and is responsible for leading Integra’s quality assurance organization. She oversees critical quality programs such as the development and implementation of the enterprise-wide compliance master plan, quality operations, post-market surveillance activities, design assurance, complaint handling, and validation.

Linnette is a seasoned senior leader with extensive global experience in quality and operations and a record of accomplishments in the medical device industry. Prior to joining Integra, Linnette was at Edwards Lifesciences for more than two decades, most recently serving as senior vice president of quality in the Critical Care division. While at Edwards Lifesciences, she also founded the Hispanic employee resource group and created chapters worldwide.

Linnette completed her undergraduate degree in industrial engineering and postgraduate studies in quality management and productivity at the Instituto Tecnológico de Santo Domingo in the Dominican Republic. She holds an MBA from Pontificia Universidad Católica Madrey Maestra. Linnette is a certified ISO 13485 lead auditor and Six Sigma Green & Black Belt.

Greg Smith is Executive Vice President, Global Operations and Supply Chain at Medtronic. He is responsible for the performance and integration of all aspects of the company’s operations including Manufacturing, Supply Chain, Supply Management, Operational Excellence and Transformation, Enterprise Risk and Facilities, and Operations Quality.

Before joining Medtronic in April 2021, Greg was the Executive Vice President of U.S. Supply Chain at Walmart, one of the world’s largest and most complex supply chains. Greg transformed Walmart’s supply chain to be best in class, developing and implementing a comprehensive strategy that drove sales, achieved operational excellence, reduced costs, and that created an engaging, enabling, and empowering work environment.

Greg is deeply committed to diversity, equality, and the belief that a diverse workplace where everyone feels included results in stronger teams and the highest level of service to our patients, customers, and employees. He was recognized as a 2020 Diversity Leader by Diversity Journal (opens new window).

Before joining Walmart, Greg was Senior Vice President, Global Operations at The Goodyear Tire & Rubber Company, where he was responsible for 52 manufacturing facilities across four business units around the world. He successfully led the company’s global optimization program and implemented an enterprise manufacturing operating system, a global procurement program, and an enterprise planning and logistics approach.

In his more than 35 years of supply chain and operations experience, Greg has also transformed manufacturing, procurement, and logistics programs at companies including ConAgra Foods, United Signature Foods, VDK Frozen Foods, and Quaker Oats.

Greg earned his bachelor’s degree in finance from the University of Tennessee, Knoxville, and he currently serves on the College of Business advisory board. He serves on the GS1 Management Board and is the Vice Chairman of its Board Committee for Healthcare. Additionally, he serves on the board of directors for Advance Auto Parts, Inc. He is also a member of the Gartner Supply Chain Executive Advisory Board.

In his role, Viju is responsible for global operations, including manufacturing, direct procurement, regulatory affairs, quality assurance, sustainability, integrated business planning, logistics and advanced operations such as additive manufacturing technology development.

Prior to joining us, Viju served as Chief Supply Chain Officer and Senior Vice President at Verizon. Before his work at Verizon, Viju held key leadership roles at Intel in technology, supply chain and manufacturing operations.

Viju earned his doctoral degree from the University of Pennsylvania and dual graduate degrees (MBA, S.M. in electrical engineering) from the Massachusetts Institute of Technology’s Leaders for Global Operations program. He also holds a graduate degree (M.S.E. in computer science engineering) from the University of Michigan and a bachelor’s degree in engineering from the University of Kerala, India.

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health.  She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture.  Dr. Tarver has held various leadership positions while at FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement.  Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation, and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the healthcare ecosystem, and stimulate creative evidence generation pathways.  Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health.  As a dedicated clinician, she continues to care for people living with inflammatory eye conditions.

Jennifer M. Paine has more than 20 years of cross-functional experience in global, executive roles in the health care medical device and diagnostics industry. She is currently Executive Vice President of Worldwide Quality, Regulatory and Compliance at Ortho Clinical Diagnostics, a global leader of in vitro diagnostics. Paine is responsible for leading the company’s worldwide quality systems, regulatory affairs and compliance strategy. She is a member of Ortho’s Executive Leadership Team and represents the enterprise on the AdvaMed Dx Board of Directors, where she serves as Regulatory Vice Chair.

Prior to her current role, Paine served as Vice President of Regulatory Affairs for Ortho, Therakos, Inc. and Veridex, LLC. Earlier, she held Regulatory Affairs roles with increasing responsibility for Ethicon, Inc., a Johnson & Johnson company, where she also served on the firm’s Management Board for its Women’s Health & Urology business. Paine started her career in Research and Development (R&D) roles before transitioning to Regulatory Affairs at Baxter Healthcare in Chicago, IL.

Paine has received numerous awards and recognitions throughout her career. She was named Board President in 2018 for the Central New Jersey chapter of the Healthcare Businesswomen’s Association. In 2017, she was named to the prestigious “Women to Watch in Med Tech” list published by Becker’s Hospital Review. She joined the distinguished class of RAPS Fellows in 2015, which recognizes senior regulatory professionals for their significant contributions and leadership in advancing the regulatory profession and the Regulatory Affairs Professionals Society (RAPS). She was honored with four Standards of Leadership Awards from Johnson & Johnson and was recognized as part of Medical Device & Diagnostic Industry’s Outstanding Quality & Regulatory Teams in 2007.

Paine earned a Master of Science in zoology from Southern Illinois University and a Bachelor of Science in biology from Rhodes College. She holds a Regulatory Affairs Certification from the U.S. Regulatory Affairs Professional Society and a Regulatory Affairs Dual Certificate in Medical Devices and Pharmaceuticals.

Paudie O’Connor is the Senior Vice President for Global Supply Chain at Boston Scientific, a position he has held since May 2022. In this role, he serves on the company’s Executive Committee and is responsible for leading the world-class Global Supply Chain team, comprised of thousands of colleagues guided by its purpose of delivering for patients. Paudie’s career in healthcare and medical technology has spanned over 26 years, serving in various roles across management, operations and engineering. Previously, Paudie served as Vice President, Planning and Customer Experience at Boston Scientific from January 2021 to April 2022 and multi-site vice president, Manufacturing from February 2015 to January of 2021. Prior roles in Boston Scientific included Vice President of the Clonmel, Ireland site from January of 2009 to February of 2015 and various engineering and operations positions in the U.S. and Ireland from 1998 to 2008. Prior, Paudie worked for Aer Lingus, PRI Automation and Integer. He is the current sponsor of the Massachusetts PRIDE employee resource group. Paudie earned a B.A. in Mechanical Engineering from Trinity College in Dublin and a master’s degree in industrial engineering from University College Dublin.

Paul brings more than 30 years of global manufacturing and supply chain experience at multinational companies with a strong track record in delivering operational excellence and transformation programmes

Prior to joining Smith+Nephew, Paul held senior roles at Goodyear, DePuy, Inc., and other Johnson & Johnson family companies

John Daley brings over 30 years of FDA-regulated industry experience to Compliance Architects. As Chief Quality Officer at JUUL Labs, he secured its groundbreaking ISO-13485 certification. John has led Quality at Johnson & Johnson, Boston Scientific, and IBM Watson Health, where he also oversaw Privacy and Security. With expertise in Design Controls, CAPA processes, combination products, medical devices, pharmaceuticals, and consumer goods, John offers a wealth of knowledge. He holds a BSME from the University of Rhode Island and an MBA from SUNY Albany.

Scott House is Abbott’s Senior Vice President, Quality Assurance, Regulatory and Engineering Services. He was appointed to this position in March 2020.

Scott joined Abbott in 1990 as a member of the Abbott Engineering Professional Development Program, and rose through a variety of management roles in both quality and operations, including Divisional Vice President, Operations for Abbott’s Diabetes Care business. Prior to assuming his current responsibilities, Scott served as Senior Vice President, Quality Operations.

In his current role, Scott leads a global organization dedicated to ensuring that Abbott’s quality, regulatory and engineering values are consistently applied across the corporation, helping ensure the highest quality products for our customers, strict compliance with global regulatory requirements, and a safe environment Abbott colleagues around the world.

“Everything we do at Abbott is geared toward helping people live their best possible lives,” says Scott. “At a fundamental level, my organization exists to help Abbott people deliver on that promise.”

Scott earned his bachelor’s and master’s degrees in mechanical engineering from the University of Louisville, and his Master of Business Administration degree from the University of Dallas.

Chester Zelaya is the Senior Vice President of Implant Network Global Operations at Edwards Lifesciences, overseeing global facilities that support both Surgical Heart Valve and Trans-Catheter Divisions. With over 30 years of leadership experience in the biopharmaceutical and medical device industries, Chester has a proven track record of driving operational excellence across diverse, multi-plant environments. Prior to joining Edwards, he held senior roles at Shire and Baxter, where he managed large-scale plasma manufacturing operations and led significant global initiatives. Chester also serves as a board member for Heart to Heart Global Cardiac Care, helping to expand access to life-saving cardiac treatments in underserved regions. His strategic vision, technical expertise, and commitment to building high-performing teams contribute to his success as a leader in the healthcare industry.

David Kunz was appointed Senior Vice President, Global Quality and Regulatory Affairs in May 2017. He is responsible for providing strategic and operational direction to achieve Quality and Regulatory Excellence across the organization and he chairs the Company’s Quality Excellence Steering Committee. Mr. Kunz joined the Company (then Zimmer) in 2011 as Vice President, Regulatory Affairs and Quality Assurance for the Spine division. He was appointed Senior Vice President, Global Quality, Clinical and Regulatory Affairs in April 2016.  Prior to joining Zimmer, he served as Vice President, Quality Assurance of Ecolab, where he led a supply chain network including nine chemical plants and two equipment plants.Previously, he spent 13 years at Guidant/Boston Scientific Corporation in a variety of leadership positions, most recently as the Director of Supplier Quality Assurance for the CRV Division. He began his career at the Naval Nuclear Propulsion Program Headquarters as a mechanical engineer. Mr. Kunz holds a Bachelor of Science and an MBA from the University of Minnesota. He is a certified Nuclear Engineer and previously was a certified Licensed Professional Mechanical Engineer.

In his role as Head of Supply Chain & Operations for Philips Image Guided Therapy Devices, Cory is responsible to lead a world-class supply chain organization and to drive operational excellence in support of the business goals, which are fully focused on providing patient-focused and market-leading solutions. His passion for building a high-performing team of supply chain and operational leaders is rooted in his belief that there is always a better, more efficient way to serve our customers. Prior to entering the diagnostic / therapeutic medical devices industry, Cory spent over 20 years in development and leadership roles in the medical device and automotive industries.