Impact Your World – Join Us at ITU Presents Sept. 15, 2016 at International Technological University

Are you ready to impact your world?

Learn from our members’ success stories how their implementation of quality concepts and tools helped them achieve company and personal goals. Learn from our panelists as they share their experiences. Following their stories, share your questions during this exciting evening at ITU.

We are pleased to present our distinguished panel: Tony Tarantino of CISCO, Austin Lin with the ASQ Board of Directors, Diane King of Gynesonics, Miguel Avila of J & J Cardinal Health, Gary Seeger of Stellartech, Govind Ramu with SunPower, and John Latimer of Xilinx. Our moderator is Barry Craner, formerly of Stellartech and ASQ Fellow.

This is a free presentation at ITU on September 15, at 6pm. ITU is located at 2711 North First Street, San Jose, CA 95134.

Register now: ITU Presents ASQ Silicon Valley

Panel Moderator: Barry Craner, Principal, CQA-Associates, Consultant to Medical Device industry on Quality Assurance and Risk Management.

Barry Craner was Vice President, QA/RA for Stellartech Research Corporation, Past Chair of the ASQ Biomedical Division, and thrice Chair of the ASQ Biomedical Division’s Northern California Discussion Group (2005 and 2014). He is in his tenth year teaching Risk Management at two universities and for ASQ.

Barry is an ASQ Fellow and has forty years of experience in the management of scientists and engineers in applications in medicine, aerospace, Internet technologies, and medical devices. He has written several design control systems for companies and has consulted in areas of reliability engineering, risk management, design control, and, quality system development, and has audited many medical device companies from first, second and third party perspectives. His advanced degrees are in Cardiac Physiology, Business Management with a Computer Information Systems emphasis.

 

Our Distinguished Panelists

 

Diane King, VP Quality & Regulatory Affairs, Gynesonics

 

Diane has served in senior management of medical device regulatory affairs for more than 19 years. For most of the past 10 years she has held the position of VP Regulatory Affairs and Quality Assurance with Gynesonics, Inc. in Redwood City. Gynesonics is the manufacturer of an incision-free alternative to hysterectomy for treatment of uterine fibroids; the product is commercial in the European Union and investigational in the United States. Previously, she was the VP of Regulatory Affairs with Alara, Inc. in Fremont, CA.  Alara’s mission was to bring low-cost digital imaging to offices and small clinics.

 

As an executive in start-up medical device companies, Diane has been personally responsible for FDA collaboration, pre-market submissions, clinical studies, compliance planning, and European regulatory requirements in the fields of ultrasound-guided radiofrequency ablation, digital imaging, bone densitometry, and light-based cosmetic therapy. She also has more than twenty years of experience in the development and management of quality systems in FDA regulated industries.

 

Diane is Regulatory Affairs Certified by the Regulatory Affairs Professional Society. She received her B.S. in Chemical Engineering with distinction from the University of Rochester.

 

Diane’s “secret”: As a quality, regulatory, and compliance executive in the start-up medical device industry, the approach that has served me best has been to always keep learning.  Understanding the true intent and benefit of quality system and safety-related regulations has enabled me to help my company comply with these regulations in a manner that makes the most sense for the organization at its current stage of development.

 

Gary Seeger, VP Quality & Regulatory Affairs Stellartech Research Corporation

Gary’s experience includes:

  • 45 years of experience in drug and medical device QA/RA
  • ASQ CQE and CRE and Senior Member of ASQ
  • BS Physics, Harvey Mudd College; MBA, UCLA
  • Vice President QA/RA at Stellartech Research Corporation, a Contract Design and Manufacturer of class II and Class III Therapeutic Energy Delivery Systems
  • ASQ NCBDG Board Member
  • Captain, jet pilot, USMC, Vietnam Veteran

Gary’s “Secret”: The relationship between character and success and why it matters.  Do the right things the right way for the right reasons.

 

 

Tony Tarantino, CISCO, Advanced Services Engagement Manager

Anthony Tarantino has over twenty years of hands-on experience running complex supply chain and IT projects in the high tech industry. This included programs to launch new core and edge routers and Lean Six Sigma projects to improve existing routers and collaboration tools.  He has also led software and tool development programs using Waterfall, Agile and Scrum approaches and hybrids.  These programs were always multi-cultural, multi-generational, cross-functional, and cross-regional (Americas, India, China, and Europe). His transformation projects focused on NPI (New Product Introduction) and outsourcing applying Lean Six Sigma tools and frameworks.

 

He began his career in the manufacturing industry as a supply chain manager for over 10 years leading multiple product launches. His span of control included all supply chain functions: purchasing, planning/forecasting, inventory/production control, logistics, spares and repairs, repair depots, physical inventories cycle counting, etc.

 

As a senior manager and practice lead for BearingPoint/KPMG’s high tech supply chain practice, he led many successful hardware projects for startups and large enterprises manufacturing products as diverse as fiber-optics (JDS Uniphase), cell phones (Motorola), and hard drives (Seagate).

 

As a Cisco recognized Six Sigma Master Black Belt, he helped Cisco Systems in process improvement initiatives to Improve NPI (new product introduction), ECOs (engineering change orders), RMAs (Return Material Authorization), and Outsourcing of Contextual Engineering. All these projects were cross-functional and cross-regional requiring strong change management and facilitation skills.

 

He recently completed his Scrum Master Certification complementing the scrum and Agile projects he has led. These projects contain elements of Lean (Kaizen), Six Sigma (voice of the customer, value stream mapping, and route cause analysis) and Scrum.

 

In the spring he will be teaching a new class in Supply Chain Risk Management at Santa Clara University’s new Supply Chain Masters program.

Tony’s “secret”: Six Sigma, Kaizen and SCRUM

 

 

John Latimer, Xilinx

John Latimer is currently Senior Director, Worldwide Customer Quality Engineering with Xilinx Corporation. John’s current responsibilities cover all aspects of customer quality from development, production, to end of life. Over the last 25 years, John has held a number of senior management & quality roles in manufacturing, process improvement, quality management, and customer engineering at organizations including Xilinx, FormFactor, Altera, Analog Devices, & Precision Monolithics.  Additionally, John is a senior member in ASQ and a member of the board for Silicon Valley Section of ASQ.

John’s ‘secret”: focusing on business value as a quality professional. How you add value to both your companies customers and it’s core operational performance.

 

 

Miguel Avila, VP Global Quality & Regulatory Affairs

Miguel Ávila is a senior business executive in the medical device industry. He currently serves as the Vice President of Global Quality and Regulatory Affairs at Cordis, a Cardinal Health company, a global leader in the development and manufacture of interventional vascular technology. He is responsible for all aspects of Quality and Regulatory Affairs worldwide. Miguel joined Cardinal Health in 2015 as Cordis’ Vice President of Global Quality and Regulatory Compliance. Prior to this time, Miguel spent over 21 years at Johnson & Johnson in various roles of increasing seniority at Cordis, Mentor Worldwide LLC, Conor Medsystems, and LifeScan. He started his professional career as an R&D chemist at Biotrack, a Ciba-Corning therapeutic drug monitoring company.

Miguel holds a Bachelor’s degree in Biological Sciences and a Master’s in Public Administration, both from San José State University in San José, CA. He is Six Sigma Green Belt certified, a Six Sigma and Lean Champion, ISO 9000 Lead Auditor certified and a graduate of the 2013 J&J Executive Quality Leadership Development program. He is a member of the American Society for Quality. He is married and the father to two children. In his spare time, he is a community leader, a published author, and serves as the editor-in-chief of a community newspaper.

 

 

Austin Lin, ASQ Board of Directors

leadership team of ASQ Silicon Valley, and presently serves on the ASQ Board of Directors. He is certified as a Quality Engineer (CQE) and as an ASQ Six Sigma Black Belt. In 2013, ASQ named Austin as the recipient of the Feigenbaum Medal, the Society’s highest international honor for a young professional. In 2015, he was elected as a Fellow of ASQ. He holds a B.S. in Chemical Engineering from Johns Hopkins University.

 

Austin’s “Secret”:

How do you work as an entry level engineer while still getting senior level work experience? While Lin benefited from his past companies’ training and development resources to grow his technical skills, in parallel he also sought out the help of professional organizations like ASQ to grow his leadership exposure. As these skills converged, he became a recognized leader in his local sections, eventually serving on the executive teams in both New York City and the San Francisco Bay Area, being awarded ASQ’s highest honor for young professionals, and then joining the ASQ Board of Directors which oversees the organization’s over 70,000 global members. These skills, Lin says, combined with being surrounded by talented and supportive colleagues, helped him excel and stand out in his daily engineering work, leading to his present role in the Silicon Valley tech industry.

 

 

Govind Ramu, Senior director, global quality management systems, at SunPower Corp. in San Jose, CA.

Govind is a licensed professional engineer (Mechanical) from Ontario, Canada. He is the chair for U.S. Technical Advisory Group (TAG) to ISO Technical Committee (ISO/TC) 176, subcommittee 1, on ISO 9000:2015 standards. He also is a member of U.S. TAG to ISO/TC 69 ASC Z1, subcommittee on statistics, and has served as an examiner for the California Awards for Performance Excellence and Malcolm Baldrige National Quality Award. Ramu is an ASQ fellow and holds six ASQ certifications: quality manager, quality engineer, Six Sigma Black Belt, quality auditor, software quality engineer and reliability engineer. He is regular author for Quality Progress magazine’s “Expert Answers” department, co-author of The Certified Six Sigma Green Belt Handbook, second edition (ASQ Quality Press, 2015), a major contributing author to The lean handbook (ASQ Quality Press 2012) and author for The Certified Six Sigma Yellow Belt Handbook (ASQ Quality Press, 2017).

 

Govind’s “secret”: My modest career growth can be attributed to setting realistic goals and staying focused,learning from experience (both mine and others) and being open to ideas.