M.B.A. – University of Massachusetts 1995
M.S. MANUFACTURING ENGINEERING – University of Massachusetts 1985
B.S. CHEMICAL ENGINEERING – Worcester Polytechnic Institute 1980

Angelo has more than 30 years experience in the Medical Device, Automotive, Consumer, Electronic, Healthcare and Chemical Industries working in development/manufacturing engineering, quality engineering, quality assurance and process improvement (Lean and Six Sigma) His background includes product development, supplier quality, (ISO 9001, ISO 14001, ISO 13485, TS 16949) quality system design and implementation, regulatory compliance and negotiations, internal and external audits and FDA submittals. His specialty areas include strategic quality planning, risk management, supply chain management, corrective and preventive action (CAPA) programs, FDA QSIT regulatory conformance for devices, validation programs, third-party assessments and HACCP analysis.
American Society for Quality: Member, Certified Lead Auditor for ISO 9001, SQF (Safe, Quality, Food) Experience, HACCP Auditor, ISO 13485 Consulting and Training experience, 21CFR820 experience

Ms. Kriss has been responsible for multisite establishment of Quality Management Systems and pre-requisite programs in both USDA and FDA regulated categories. Skilled in regulatory affairs and regulatory management in crisis situations such as product withdrawals and recalls.

Ms. Kriss also is the co-author and presenter of a course sponsored by Rutgers University (Fall 2009) in the “Practical Approach to Listeria management in RTE and other high risk foods”.

Debra’s skill set goes outside of quality and regulatory affairs into manufacturing where she has managed, re-engineered and designed USDA regulated RTE facilities. She is fully knowledgeable in equipment design and is responsible for designing the first true triple wash spinach equipment with a kill step.

Cathy has over 15 years prior experience in consulting, food manufacturing, and food chemistry / microbiology laboratories. She was the Director of Regulatory & Technical Services for a privately owned meat and poultry processing company where she was responsible for regulatory compliance, developing food safety strategies, ensuring appropriate export programs, and coordinating recall responses when necessary.

Specializing in food defense programs, she was the instructor for a series of food defense workshops sponsored by the USDA Food Safety Inspection Service (FSIS). She also facilitated national focus group meetings, bringing together industry, trade association and FSIS representatives to produce new model voluntary food defense plans and FSIS Guidance Material.

• Registered Consultant and Auditor for Safe Quality Foods (SQF)
• Certified Instructor- National Restaurant Association’s ServSafe Program
• Certificate in International Food Law - The Institute for Food Laws and Regulations, Michigan State University
• M.S. Food Safety – Michigan State University
• B.S. Biology – Arizona State University

Russ has had over 30 years experience as a quality professional working in both the service and manufacturing environment.  He has held positions of increasing responsibility leading to the Director of Quality for a large national company.  As director he has lead the company through implementations of:  ISO 9000, ISO 14000, Six Sigma and Lean initiatives for both support and manufacturing locations. 

Russ has worked as implementer, trainer, facilitator, program manager, and lead auditor for business management systems, quality management systems, and continuous improvement programs.   He had facilitated the implementation of ISO 9000 and ISO 14000 in 23 manufacturing locations, customer service center, field service group and distribution centers.  He managed a Six Sigma program resulting in the training of over 400 green, black, and master black belts with a savings to date of about $150 million dollars.  Russ had also introduced a corporate-wide lean program based upon the applied learning through Kaizen Events.  Russ’s manufacturing experience includes chemical, glass, plastic molding, electronic assembly, and lamp assembly processes in the commercial, consumer and automotive industries. 

Tura has over 12 years experience in quality management systems, participated in the implementation of six sigma projects for GE in Mexico, as well as automotive auditing and project management in Germany at VW, AUDI, BMW, among others. Participation in quality system audits for different industries to name a few, the food, textile, machine/metal, plastics, electronics, and medical located in the US, Mexico, Germany, Italy, and Spain. Auditing in three different languages: Spanish, English, and German. Most recently worked at the certification body of a European registrar as a technical engineer and auditor, and achieved the following accreditations to the registrar: SQF (Safe, Quality, Food) and RC (Responsible Care) besides maintaining and implementing the internal QMS of the following accreditations with ANAB, SCC, and DAR: ISO 9001, AS 9100, ISO 13485, ISO/TS 16949, TL 9000, ISO 14000. Technical reviews for compliance in ISO 17025, and OHSAS 18001. BS degree in Industrial Engineering from the University of Monterrey, Mexico. Lead Auditor for ISO 9001:2000.

Derek’s quality background includes certifications as a Six Sigma Black Belt, Lean Expert and ISO 9001:2000 Auditor. In addition, he has a B.A. in Communications. He has worked with high tech, manufacturing and service based organizations to improve performance and ensure compliance with quality standards.

As a continuous improvement engineer he brings a number of effective quality skills and tools to bear in solving quality problems as well as implementing continuous improvement strategies. These include: Process Mapping, DMAIC Process, Supply Chain Management, Kaizen, Change Management, Flow Management, Statistical Analysis, FMEA, DOE, Auditing and Testing, Root Cause Analysis, Total Productive Maintenance and Statistical Process Controls.

Diane H. Schmalensee, President of Schmalensee Partners, has over 25 years experience in helping clients increase customer and employee loyalty and boost their competitiveness and revenues. She specializes in listening to internal and external customers and using measurement and management skills to guide marketing, research, operations and corporate strategies. Clients seek her out when they face challenging customer or employee measurement or strategy-related situations that require experience, agility, credibility or connections.

Ms. Schmalensee has worked with service organizations of all sizes on their marketing and improvement plans. Her clients include such award-winning companies as AT&T (American Transtech Florida Award Winner and Universal Card Baldrige Winner), Clark & Reid (Massachusetts Award Winner), Datatel (Virginia Award Winner), Delta Dental of Massachusetts (Massachusetts Award Winner), Northeast Delta Dental (winner of many awards as an employer and corporate citizen) and dozens of other highly regarded organizations. Many of her clients have experienced impressive gains in revenues and satisfaction after working with her.

Before founding Schmalensee Partners in 1991, she worked as Vice President of the Marketing Science Institute, as Vice President of Opinion Research Corporation, and in research for major regional advertising agencies. She holds an MBA from San Diego State University and a Bachelor's degree from Wellesley College.

Denise Robitaille is the author of eight books. She is an internationally recognized speaker who brings years of experience in business and industry to the quality profession. In 2005, she was recognized in Quality Digest as one of the “Drivers of Quality.” She is a member of US TAG to ISO/TC176, the committee responsible for updating the ISO 9000 family of standards. She is a RAB-QSA certified lead assessor, an ASQ Certified Quality Auditor, and a senior member of ASQ.

Denise has helped numerous companies in diverse fields to achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as document control, corrective action, root cause analysis, management review, auditing and implementing ISO 9001. Denise’s other books include: The Corrective Action Handbook, The Management Review Handbook, Document Control: A Simple Guide to Managing Documentation, The Preventive Action Handbook, Root Cause Analysis: Basic Tools and Technique and Managing Supplier Related Processes. She is a regular columnist for Inside Standards and The Auditor and is the author of numerous articles.

Betty Lane has over 20 years experience in Medical Device quality assurance and regulatory affairs. She has established or updated quality systems for numerous small and medium sized medical device and diagnostic companies. Her accomplishments enabled these companies to manage their business in compliance with FDA and ISO 13485 requirements, thus enabling worldwide sale of their products. Her background in digital systems engineering, enabled her to facilitate design controls and software validation when they became FDA and industry requirements.

Accomplishments include:

-Implementing ISO 13485in 6 months, for several companies
-Established the quality system for PB Diagnostics (later Behring Diagnostics), and obtained ISO 9001 certification for -Instrumentation Laboratories in Lexington, MA, among others
-Taught courses at Northeastern University, Boston MA, in Regulatory Affairs and cGMP
-Taught AAMI Quality Systems Regulation and Design Control courses, which provide comprehensive training for both i-industry and FDA personnel.
-Member of the Advisory Board of DQS, Inc.., a world wide RAB accredited ISO 9000/QS9000/AS9000 registrar for over 20 SIC categories
-Featured in Journeys of Women in Science and Engineering, No Universal Constants, by Susan A. Ambrose, et. al., Temple University Press, 1997.

Betty is the founder and President of Be Quality Associates, LLC, a consulting company helping medical device companies implement and improve their quality systems for both business improvement and regulatory compliance. Other services included training, auditing, supplier management and medical device quality system software validation.

Chuck Gillis is a certified Master Black Belt and Lean Leader, a Quality Support Group senior consultant and the owner of Work Stream Consulting. Chuck has over 30 years of industry experience in semiconductor manufacturing technologies and operations management. For the past 12 years he’s been involved with continuous improvement efforts starting in 1998 as M/A-COM’s first Black Belt, to the first certified Master Black Belt for Tyco International in 2004. Chuck has served as a business unit coordinator for site projects, managing a global portfolio of projects, belts and resources, in addition to providing training and support for operational Six Sigma, Lean Design and Lean efforts. Chuck is experienced in all phases of Lean Six Sigma deployment from partner selection to roll out in a $1B operation. His experiences with Tyco International allowed him to develop a keen sense of the applicability of the continuous improvement tools across all facets of the corporation from semiconductors and electrical components to catheters and pre-packaged surgical packs, all the way to rolls of duct tape.

Chuck serves as a speaker and a judge for IPQC (International Productivity and Quality Center) as well as a contributor to Six Sigma IQ. Chuck has a BS in Applied Sciences and has done graduate work in business management. He is also a senior member of American Society for Quality.