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

For over 30 years, David has been in the Quality field holding positions including Quality Manager and Principle Quality Engineer and the last 3 years as a consultant. David has consulted with various companies doing tasks including evaluating and improving processes such as corrective action, internal auditing and many others. David has provided training in many different areas including: Lean Manufacturing, SPC, Process Improvement, Auditing, etc. David has also done extensive Quality auditing; both supplier auditing of more than 100 companies and internal auditing to ISO 9001:2000, AS9100, ISO 13485 and cGMP standards. The types of industries that David has been involved with range from Medical Device to High Tech to Service Industries where he has created and improved processes and systems that have saved money, time and effort for those companies.David has a bachelor’s degree in Mathematics. A senior member of the American Society of Quality (ASQ), former chair of the Worcester ASQ section and a 6-sigma black belt, he has the following certifications from ASQ: CQMgr, CQE and CQA.

W.R. (Bill) Harding with over 35 years of manufacturing experience in a high tech industry with G.E. Aviation Division. Bill is a Six Sigma Certified Black Belt and a Master Certified Lean Manufacturing Leader. Bill has over 23 years of flow technology experience in many of the different disciplines ranging from: Theory of Constraints (TOC),Just-in-Time ( JIT), Demand Flow Technology (DFT), Thruput, Lean and The Toyota Production System (TPS). Also, Bill has over 18 years experience consulting with GE Suppliers and Customers worldwide. In addition, Bill has received extensive training in the Toyota Production System from the Shingijutsu Consulting Co., Gifu, Japan.

Bill has over 25 years of senior management operations, production, and industrial engineering experience maximizing business performance utilizing existing best practices. His background includes driving technical systems support for two national retailers, and streamlining operations within four manufacturers. He has been consulting, training, and coaching full time for 7 years focused on both strategic and tactical improvements to build operational capabilities such as Lean/Six Sigma, and ISO 9001, OSHAS 18001, ISO 14001, AS9100, and TS 16949 quality assurance systems compliance.. Also, Teams based management, risk mitigation, and implementing performance measurement systems is a strong focus. He is experienced in conducting strategic business assessments and business turnarounds, implementing various quality systems such as ISO, AS, TQM, Lean Processing, and supplier based alliances. He has conducted numerous HR training courses in supervisory management, executive leadership, and installing performance measurement systems. He has been invited to speak at several industry gatherings to share lessons learned while implementing breakthrough projects.

Doug has over twenty years of quality experience, including positions as a Quality Engineer, Senior Quality Consultant, Supplier Quality Supervisor, and Quality Manager. He established, improved and managed ISO 9001 quality systems at small, medium and large electronics companies. Doug worked closely with suppliers on quality assurance qualifications, audits and corrective action. He setup and led continuous improvement teams using tools such as Ishikawa diagrams, Kepner-Tregoe analysis, Failure Mode and Effects Analysis (FMEA) and Affinity diagrams. Doug established and managed effective customer satisfaction programs, including simple email surveys with over 30% response rate and proactive corrective and preventative action processes. He has been the ISO 9001 Management Representative at several companies with responsibility for all Quality Assurance activities, including ISO 9001 registrar audits.

Doug also has extensive Design Engineering, Project Management, Manufacturing Engineering, New Plant Startup and New Product Introduction experience as an individual contributor and manager at several companies located in Massachusetts, New York, Vermont and Puerto Rico. He has been a Senior Member of the American Society for Quality since 2002. Doug has Electrical Engineering degrees from the University of Buffalo (BSEE) and Northeastern University (MSEE) and took MBA courses at Babson College.

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.

Ms. Crawford is an enthusiastic trainer who has provided HACCP and other food safety training to a wide variety of businesses including meat and poultry processors, bakeries, fruit and vegetable processors/packers, and food service establishments. In addition to her contributions a member of the Quality Support Group, she is also a Vice President of the HACCP Consulting Group, LLC, and an adjunct instructor at the Culinary Institute of Virginia.

• Registered 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

James F. Leonard is a consultant and educator who specializes in teaching the principles of the late Dr. W. Edwards Deming as a new system of management. He helps organizations implement systems for improving quality, productivity, and competitive position. Jim’s clients come from a wide variety of industries, including power generation, electronics, health care, chemicals, robotics, biotech, injection molding, medical devices and consumer products. He has also worked with service organizations, schools and government agencies.
Jim attended the U.S. Naval Academy, majoring in Mechanical Engineering and Analytical Management. He completed his Bachelor of Science degree at the George Washington University, and later earned his graduate degree in Organization Development from Clark University. Jim served on the New England Deming Prize Committee, the American Quality and Productivity Institute’s Education Forum, and the Juran Institute’s Advisory Committee for Quality in Service Industries. He also served as a member of the Board of Directors for Delta Systems, Inc., and assisted Dr. Deming in Deming’s four-day executive seminar, Quality, Productivity and Competitive Position.

David has 32 years experience in manufacturing as an internal consultant, corporate trainer, and quality manager. As a quality manager for the last 14 years, David has led three organizations to ISO9001 certification including ISO13485 and compliance with 21 CFR 820 regulations. His background includes managing internal and supplier audits, improving corrective/preventive action systems, implementing balanced scorecards, risk assessment, supply chain management, SPC techniques, customer satisfaction surveys, and cGMP compliance.

When managing projects, David’s primary focus is to satisfy customer requirements and achieve positive business results. Project implementations have utilized lean/Six Sigma techniques to improve key performance indicators such as cost savings, cycle time reduction, higher production yields, and improved customer satisfaction.

David holds a B.S. in Business Administration and an M.A. in Business and Policy Studies from the State University of New York. He is a senior member of the American Society for Quality (ASQ). His professional certifications include CMQ/OE, CSSBB, CQA, CQE, and RABQSA - Auditor.

Eb has a Masters degree in Mechanical Engineering from the RWTH Aachen in Germany and holds certificates from the DGQ (German equivalent of ASQ) in Statistics, Quality Management and Quality Auditing. He is an ASQ member since 2003.

Eb has worked in the areas of quality and operations in various global companies of the consumer industry. He has introduced and implemented Quality Management Systems according to ISO 9001 and 14001 in Germany and the US and has many years of experience working with standard quality tools like FMEA, SPC, Pareto, Fishbone diagrams, etc. He has been involved in restructuring programs allowing double digit savings through the implementation of Lean Management and Lean Manufacturing tools.

Eb has a Masters degree in Mechanical Engineering from the RWTH Aachen in Germany and holds certificates from the DGQ (German equivalent of ASQ) in Statistics, Quality Management and Quality Auditing. He is an ASQ member since 2003.

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. 

Ed brings 30 years of Quality and Component Engineering background to QSG.  Ed has worked at least five years each as a Component Engineer, Quality Control Engineer, Quality Assurance Engineer, and ten years as a Quality Manager and ISO Management Representative.  He is currently helping four companies become registered or maintain registration to ISO-9001:2000.  Ed has degrees in Electronics, Industrial Technology and Computer Information Systems.  He has been certified as an ASQ Quality Auditor, Software Quality Engineer and Quality Manager.

Bob has over 40 years of manufacturing experience in the semiconductor industry. During that time Bob has held senior management positions in industrial, process engineering, package assembly, manufacturing, quality and reliability. He has also held, in between managerial assignments, individual contributor roles as a senior staff and consulting engineer in quality and reliability. Bob has started new business opportunities in a large corporation and has significant experience in process development and certification, process transfer, new product introduction into manufacturing, quality system design and assessment, corrective and preventative actions, process change control, non-conforming material, process and product yield analysis, statistical process control and failure analysis in a multi-factory environment. Bob has a BS&MS in Metallurgy and Material Science from Lehigh University.

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 Churchill spent the past 13 years in the communications and quality consulting industries. He has extensive experience in communications, operations management, project management and regulatory compliance. He has a long history of developing and leading continuous improvement efforts. In addition, he has a lengthy background as a company trainer.

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.

Bachelor of Science, Human Resource Management, State University of New York
Design for Six Sigma Certification
Six Sigma Champion Certification
Lean Manufacturing Champion Certification
Certified Customer Delight Instructor
Certified Navy Master Training Specialist
Total Quality Management Certificate
Instructional Systems Design Certificate
Ford Q1 Certified Quality Trainer
ISO 9000 Lead Auditor Certificate
U.S. Navy Nuclear Power School
Navy Quality Assurance School

Developed and facilitated corporate Six Sigma, Lean Manufacturing, and QS 9000 training efforts. Facilitated the implementation of Self-Directed Work Teams. Implementing computer based training and pay-for-skills program. Designed and implemented corporate professional development plan that included a comprehensive STAR points program, professional skills development, mentoring program, and performance appraisal process.

Facilitated the implementation of a High Performance Work Organization team concept within a union environment. Facilitated a team implementation steering committee. Provided a variety of team development training services.

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.

Lori Kahler is President of The RC Insight Group with offices located in Rhode Island and Washington, DC. The RC Insight Group is a leading provider of global regulatory and clinical consulting services, competitive intelligence and strategic planning for the medical device and biotechnology industries. Ms. Kahler is a highly accomplished professional in regulatory and clinical affairs with strong multi-functional regulatory, clinical and quality assurance expertise. Her primary focus has been helping customers with the development of strategic new and enhanced product lines marketed both domestically and internationally. Ms. Kahler founded The RC Insight Group in 2009. She was the Director of Quality and Regulatory Affairs for Heartlab, LLC (acquired by Agfa-Gevaert) from 2000 to 2005. From 2005 to 2007, she was Global Director of Quality Assurance and Regulatory Affairs of the Cardiovascular Business Unit for the Agfa Gevaert Group. Prior to establishing The RC Insight Group, Ms. Kahler was Vice President of Quality Assurance, Regulatory and Clinical Affairs for Ximedica, LLC from 2005 to 2007.