QUALITY SUPPORT GROUP - Key Persons

Job Titles:

• Senior QMS Consultant for ISO, Aerospace, and Automotive

Al Scorza is an accomplished Quality Professional with a broad range of experience in Quality Management and Quality Engineering, Program Management, Auditing, Supervision, and Training. For 37 years Al worked as a Senior Quality Engineer and Process Senior Quality Engineer for Bose Corporation, where he was a QMS Program Manager for TS/ISO, MRB Engineer, and Lead Auditor. He subsequently worked as a Quality Manager for multiple small manufacturers and has extensive experience with internal Corrective Actions, as well as for customers and suppliers, Control Plans, FMEAs, First Piece Qualification Inspections, Continuous Improvement, and Internal Auditing. Al's QMS experience encompasses ISO 9001, AS9100, and TS 16949. He holds a degree from Dean College and a BSBA degree from Bryant University with a major in Management.

Job Titles:

• Consultant, Quality / Regulatory Systems / Professional Development

Alyce Nelson holds a bachelor's degree in Mechanical Engineering from the University of California, a post grad certification from MIT in Cardiovascular Anatomy & Pathophysiology for Scientists and Engineers, a diploma from the Krieger Institute of Canada in Clinical Research, an Exemplar certification as a Lead Auditor for Medical Devices, and a certification as a Professional Leadership Coach and Life Coach through the Institute of Professional Excellence in Coaching (IPEC), born out of Harvard and accredited by the International Coaching Federation. Alyce has spent over 30 years in the medical device industry, 20 of which have been in the start-up arena, in Class II and Class III medical devices. Her most notable start-up experience was with ACS, which later became Guidant after the Eli Lily acquisition. She has worked in the product areas of spinal implants, bioresorbable implants, oxygenation, filtration, catheters, stents, guidewires, defibrillation, ablation, IVD, concussion, and sleep diagnostics. Alyce began her career with an initial engineering emphasis on pilot development manufacturing, progressing to new product development, R&D, and later into process engineering, and project management. After covering this breadth of engineering, she changed things up by expanding into quality, regulatory, and clinical attaining the highest position of Vice President before beginning her own successful consulting, training, and coaching practice where she's delivered in the areas of mergers and acquisitions, establishing quality systems, auditing, EU-MDR transitions, CAPA and Complaints, expert witness, clinical trials monitoring, recalls, risk management, department turn arounds, and difficult remediations. Alyce served 2 consecutive terms on the Advisory Board for the CBI Summit on Product Recalls held jointly in Washington DC with the FDA and serves on the faculty of QSG (Quality Support Group). She holds professional affiliations with Medical Device Group-Boston (MDG), American Society of Quality (ASQ), Regulatory Affairs Professional Society (RAPS), and is also active with the International Coaching Federation (ICF), and National Speakers Association (NSA). In her spare time, she enjoys many outdoor activities, hanging out with her beagle, entertaining, singing, Patriots football, and is an avid reader.

Job Titles:

• President
• Instructor at Northeastern University

Barbara has over 15 years of professional experience in the financial, nonprofit, and manufacturing industries. Her areas of expertise are leadership, management, strategic planning, instructional design, sales training, and development. Barbara aligns business objectives with customized training solutions. Barbara is currently an instructor at Northeastern University, where she has teaches in the business and leadership programs to a worldwide audience. She is a former instructor at Endicott College. Barbara holds a Master's Degree in Business Administration from Endicott College and a Bachelor's Degree in Liberal Arts from Assumption College.

Job Titles:

• Senior Consultant, Food Safety / Quality / HACCP

Cathy has over 20 years of experience in food manufacturing and food chemistry/microbiology laboratories. Her work has included regulatory and global food safety compliance, developing food safety strategies, ensuring appropriate export programs, and coordinating recall responses. Cathy's instructional experience includes teaching a series of food defense workshops sponsored by the USDA Food Safety Inspection Service (FSIS), and she has facilitated national focus group meetings, bringing together industry, trade association, and FSIS representatives, to produce model voluntary food defense plans and FSIS Guidance Material. Cathy is an enthusiastic HACCP and food safety trainer for a wide variety of businesses, including meat and poultry processors, bakeries, fruit and vegetable processors/packers, and food service establishments. She was an instructor at the Culinary Institute of Virginia and is President of the HACCP Consulting Group, LLC. Cathy is a former Safe Quality Food (SQF) auditor and now shares her knowledge as a licensed SQF Trainer. She is also a Lead Instructor for the Food Safety Preventive Controls for Human Food course. Cathy's credentials include a Certificate in International Food Law from The Institute for Food Laws and Regulations at Michigan State University. She received an M.S. in Food Safety from Michigan State and a B.S. in Biology from Arizona State University.

Job Titles:

• Senior Consultant, Supply Chain Management

Cynthia is internationally recognized as an influential Ph.D. focused on supply/service chain performance and business growth. Melding her industry, academia, and federal government experience, Cynthia consults, mentors, and provides training in business and supply chain performance strategy, digital transformation, and rapid competitive stance improvement. Since 2001, her company, Process & Strategy, has been helping organizations increase scale and grow successfully without chaos and with revenue generation.

Job Titles:

• Consultant, Lean Six Sigma

Dave Margil spent a decade driving Lean deployment at Bose Corporation, focused primarily on IT while also partnering with Consumer Electronics, Research, Automotive, and Sales. He has been responsible for developing organizational Lean deployment roadmaps, driving Lean Six Sigma practices, leading value stream improvement activities, contributing to curriculum development, and delivering training and coaching to turn classroom concepts into tangible, business improvements. Since 2016 he has also been a Lean Six Sigma coach for organizational leaders enrolled in the Master of Business Operational Excellence (MBOE) program at The Ohio State University, helping them achieve breakthrough results. Prior to his Lean deployment role, Dave spent several years as a Business Engagement Manager and as a Project Manager in the Bose Online Commerce Group. Before joining Bose, he cofounded and spent several years as the VP of Product Development for a Cambridge, MA-based computer game company. Dave is a certified Master Black Belt, certified Change Manager, and certified Scrum Master and has a Bachelor of Fine Arts from the University of Massachusetts.

Job Titles:

• Consultant, Quality / Regulatory Systems / ISO 13485 / Second Party Audits

David has over 35 years' experience as a consultant and auditor within several industries such as public utilities, glass production, consumer product printing, metal fabrication, thermal packaging, and medical device. David has led four organizations to ISO9001 certification including ISO13485 and compliance with 21 CFR 820 regulations. He has a special expertise in providing consulting and auditing services for producers of medical devices and pharmaceutical drugs. Some of his clients have included Johnson & Johnson, Merck, Baxter, Janssen, Abbott, Hospira, Samsung Biologics, and Amgen. David has worked with companies providing medicinal drugs, skin treatment products, dental supplies, precision machining operations, injection molding, diagnostic imaging, inspection, testing and calibration labs, coating and service treatment operations, software developers, warehousing and distribution centers, and transportation of temperature controlled drug products. As an auditor and consultant, David's primary focus is to ensure compliance with relevant quality and regulatory standards and to assess the effectiveness of an organization in meeting planned objectives. 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: Certified Manager of Quality and Organizational Excellence CMQ/OE Certified Six Sigma Black Belt CSSBB Certified Quality Auditor CQA Certified Quality Engineer CQE Exemplar Global - Certified Auditor

Job Titles:

• Consultant, Lean Six Sigma / Process Improvement

Don has over 30 years of engineering and manufacturing experience in the semiconductor industry. He has held both management and senior staff member positions in process engineering, test engineering, manufacturing, quality, yield improvement, business operations, industrial engineering, and planning. He has extensive experience with business process development, process change management, statistical process control, waste elimination, inventory control, product life cycle management, structured problem solving and cost reduction. He was part of a team that led Intel's manufacturing organization through a lean transformation that resulted in significant cycle time reductions and cost savings. Don's area of training and consulting expertise include lean six sigma, problem solving, process mapping, Kaizen events and other lean initiatives. He has been with Quality Support Group since August of 2016. Don is a certified Project Management Professional (PMP) and has had extensive training and over fifteen years of experience with implementing lean initiatives. He received his B.S. in Electrical Engineering from Cornell University.

Job Titles:

• Senior Consultant, Operational and Organizational Excellence

Dr. Wilson is a trusted guide to lasting operational improvements through engaged associates and sustainable behavior changes. She brings almost 40 years of technical, managerial, manufacturing, consulting, and leadership experience to client companies to create value and lasting improvements by training and coaching in leadership skills, facilitating Kaizen events to improve business results and people's lives, and providing succinct written documentation. Dr. Wilson has implemented transformations across a wide variety of industries such as wood products, medical devices, paper mills, machine shops, automotive suppliers, engineered products, food manufacturers, commercial greenhouses, and printers. She has coached site managers, champions, and associates during the change process; taught lean tools to over fifteen hundred adult learners with an average evaluation score of 4.8 on a scale of 1 to 5; and helped clients realize cost savings, improvements in associate morale, and reduction in lead times and quality defects. Dr. Wilson believes that leadership exists at all levels and social systems in an organization and that success relies on learning, communicating, and collaborating across various groups. Her educational background includes a DA in Leadership from Franklin Pierce University, an MBA from Rensselaer Polytechnic Institute, and BSBEE/BSEE from the University of Rhode Island.

Job Titles:

• Consultant, Quality / Regulatory Systems
• QMS Transformation Consultant

Eric Pettes is an experienced QMS transformation consultant with over 25 years of experience in medical device, medical consumables, pharmaceutical consumables, and parental drug injectables. He has held VP QA/RA positions for medical device and combination product contract manufacturers as well as medical device OEM's. Eric has worked for companies including Jabil (Nypro Healthcare), Philips-Medisize, Hologic and Bose, where he led their entry into Medical Device arena with the launch of the world's first over-the-counter hearing aid. Eric's experience encompasses capital equipment, software/SaMD, combination products such as injectors/inhalers, surgical equipment, and consumables/disposable products. He specializes in helping small companies create/upgrade their quality systems, become FDA/ISO audit ready and Establishment Registration ready. Eric has significant experience managing FDA Inspections, and in writing and responding to FDA 483 Inspection Observations. Eric has successfully managed many ISO 13485 transformation/certification initiatives in North America, Europe, and Asia-Pacific helping consumer-based companies make the transition to medical device. Eric received a B.S. in Business Administration from the University of New Haven, an M.S. in Organizational Leadership and Quality from Marion College and an M.S. in Psychology from the University of Phoenix.

Job Titles:

• Consultant
• Senior Consultant, Process Improvement and Statistical Methods

James F. Leonard is a semi-retired consultant and educator who specializes in teaching the principles of the late Dr. W. Edwards Deming as a new system of management. He has worked with manufacturing and service organizations throughout North America, Europe, and in China. Jim serves as a senior consultant for Quality Support Group in Westford, MA.

Job Titles:

• Consultant, Quality and Regulatory Systems
• QMS Trainer and Consultant

John Nagle is an experienced QMS trainer and consultant with over 30 years of experience in medical device, medical consumables, pharmaceutical consumables, and parental drug injectables, as well over 20 years in the In Vitro Diagnostics industry. He has held positions in companies ranging from 10-20 person startups to multinational companies. John has worked for companies including Nova Biomedical, Foundation Medicine, IQuum, GE Healthcare, Genzyme, Roche, and Medispectra Inc.. John has held several Head of Quality positions as part of his consultancy work for multiple VC start-up companies. John's experience encompasses capital equipment, software, and consumables/disposable products. He specializes in helping small companies create/upgrade their quality systems, become FDA/ISO audit ready and Establishment Registration ready. John has significant experience managing FDA Inspections (including BIMO), and in writing and responding to FDA 483 Inspection Observations, PMA Deficiency letters, and Product Recall communication responses. John has successfully managed ISO 13485 certification projects for both US and EU companies. John attended the University of Lowell (Mechanical Engineering) and studied Information Services management at Northeastern University and Human Relations through Dale Carnegie Training. He is a member of ASQ, PDA Parenteral Drug Association, Regulatory Affairs Professional Society, Mass Medic, and AdvaMed.

Job Titles:

• Business Manager

Job Titles:

• Consultant, Quality Systems

With three decades of experience, Joseph (Joe) DeCarlo has an extensive background in quality, sales, business development, marketing, and operations. He has a proven track record of successful assessment and training activities in organizations he's worked with, improving their quality and revenue capabilities. Joe has strong problem solving and leadership skills and shows flexibility in his approach. Joe performed regulatory training, consulting, and assessments for Fortune 500 companies and governmental agencies, and has experience with regulatory submissions for class I devices. He has considerable expertise in quality management systems, having implemented systems with over 250 organizations and having worked in a variety of roles with notified bodies (LRQA, SAI Global, and TÜV Rheinland). Joe is a former product safety engineer who has conducted safety testing and certification of electrical products for safety compliance to domestic and international standards. He is a recognized expert in training for internal auditors and comes highly recommended for this skill by former colleagues. For Oriel STAT A MATRIX, Joe has conducted numerous public venue training courses across the breadth of their offerings; he has trained and consulted at many high-profile corporate and federal organizations. As division manager at one organization, he helped to establish a quality systems group responsible for conducting quality assessment and training programs in North America. Joe has conducted executive training/coaching and assessment events for Fortune 500 companies and has managed and coached teams of consulting professionals and office staff. As a key member of a senior management team, he was a noted speaker on sales, quality, and operations. Joe has presented working sessions at Harvard University, Columbia University, CCSU Northeastern, and Fairfield University. He served as Executive Chairman for the Danbury CT ASQ and is a trained Wish Granter and volunteer with Make-A-Wish Foundation of CT.

Job Titles:

• Senior Consultant, Agile, Scrum & Project Management

Nicholas brings 20 years of experience leading global initiatives for CRM, ERP, and Product Development platforms. He spent 10 years with SAP as an Application Developer, Service Delivery Consultant, and a Sr. CRM Consultant. Nicholas's expertise includes Project Methodology (Agile/Scrum, Waterfall) and Innovation Methodology, and he is a Certified Scrum Master, PMP, and a Risk Management Professional. Nicholas holds a B.A. in Business Information Technology, and an Executive MBA from the Frankfurt School of Finance & Management. He lives in Christ Church, Barbados.

Job Titles:

• Senior Consultant, Lean Six Sigma

Peter has 25+ years of experience driving Continuous Improvement initiatives. His career has included four years as Director/Process Excellence with Cbeyond, 10 years as Master Black Belt with AT&T's Product Development Group, and four years as Lead Instructor at Emory University's Six Sigma Program in Atlanta. He has served as Section Chair and Programs Chair for ASQ Atlanta Section 1502. Peter has advanced degrees from MIT and Georgia State University and worked with Dr. Edwards Deming while in Japan as a visiting MIT Scholar. He and his family of five live in Dunwoody, Georgia.

Job Titles:

• Consultant, Food Safety / Quality
• Member of the International Association for Food Protection

Mr. Savage received his B.S. and M.S. in Food Science and Technology from the University of Massachusetts and has more than 44 years experience in the food industry, the United States Food and Drug Administration (FDA), the United States Department of Agriculture, Food Safety and Inspection Service (FSIS) and the HACCP Consulting Group, L.L.C. Mr. Savage served as the Director of Microbiology for the Ann Page Division of the Great Atlantic and Pacific Tea Company where his duties included developing microbiological methods, establishing microbiological specification for new products, QC sampling plans, thermal process schedules for low-acid canned foods and trouble-shooting microbiological problems. While with FDA, Mr. Savage was active in the implementation of the first HACCP-based, low-acid canned food regulations, investigations of botulism outbreaks, product recalls and evaluations and audits of firms' compliance with FDA regulations both domestically and overseas. He is considered a leading expert in thermal processing technology. In the FSIS, Mr. Savage was responsible for the development of the HACCP-based, canning regulations for meat and poultry products. Mr. Savage served as the Headquarters representative on a six-member HACCP Special Team to study how HACCP would be used in the meat and poultry industry and in the inspection program. Duties included conducting HACCP workshops with leaders in the meat and poultry industry and pilot testing HACCP models in volunteer slaughter and processing plants. He also participated in the development of the HACCP regulations and HACCP guidance materials for small business. While at FSIS, Mr. Savage conducted numerous HACCP training sessions for both industry and Agency personnel and is accredited as a Lead Instructor and a Train-the-Trainer by the International HACCP Alliance. Mr. Savage served as President of HACCP Consulting Group from 1996 until March, 2016. With HCG, he has taught numerous HACCP, Sanitation Standard Operating Procedures (SSOPs), Good Manufacturing Practices (GMPs), and HACCP audit courses for the food industry (e.g., meat, poultry, airliner catering, etc.) both in the United States and Internationally. Mr. Savage has travelled to over 20 countries to provide food safety, regulatory enforcement training and assistance to foreign countries (both industry and government inspection personnel) to become eligible to export meat and poultry to the U.S. Other activities have included food safety assessments of plants' HACCP Plans, GMPs and SSOPs. Mr. Savage has also worked with the North American Meat Association, the American Meat Institute and the former Food Processing Institute to provide HACCP instruction. Mr. Savage is a member of the International Association for Food Protection and has published numerous articles dealing with HACCP, HACCP Plan Validation, FSIS In-Depth Verification (IDV) Reviews and Implementation of SSOP Programs. Mr. Savage is also the recipient of the 2000 Professional of the Year Award from the National Meat Association (NMA). Mr. Savage also served as a member of the NMA, Board of Directors and the International HACCP Alliance.

Job Titles:

• MIDWEST OPERATIONS - DETRIOT, MI

Job Titles:

• Consultant, Software Engineering

Steven R. Rakitin has over 40 years experience as a software engineer and software quality manager. He has written extensively on the subject of software quality and published a book titled Software Verification & Validation for Practitioners and Managers, 2nd ed. He has worked on several IEEE Software Engineering standards committees and was a member of the AAMI HIMSS CE-IT Collaboration team. As a member of a joint AAMI/FDA committee, he helped write the Recommended Practice for the Application of Quality Management System Concepts to Medical Device Data Systems, AAMI SW87:2012. He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He has earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a member of the IEEE Computer Society, ASQ Software Division, ASQ Biomedical Division, and the Association for the Advancement of Medical Instrumentation (AAMI), and the Massachusetts Medical Device Industry Council (MassMEDIC). He is on the Editorial Review Board for the ASQ Journal Software Quality Professional. He has presented invited papers and tutorials at conferences worldwide for the Health Industry Manufacturers Association, AAMI, ASQ, and IEEE. As president of Software Quality Consulting Inc. (www.swqual.com), he helps medical device manufacturers comply with regulations and standards for software. He has worked with over 85 medical device manufacturers including startups through Fortune 500 companies. He can be reached at steve@swqual.com.

Job Titles:

• Consultant, Environmental Management Systems / ISO 14001

Susan L.K. Briggs is known nationally and internationally for her work developing and implementing Environment, Health and Safety Management Systems in manufacturing, research and government organizations. Chairperson of the U.S. Technical Advisory Group on Environmental Management, representing the US in the negotiation of ISO Environmental Standards requirements. Former member of the ANSI-ASQ Accreditation Council overseeing the accreditation of certification bodies in the U. Member of the ISO Joint Technical Coordination Group task force that wrote ‘Annex SL', ISO's core management system requirements and the related guidance now used in all ISO management systems standards. Susan L.K. Briggs is known nationally and internationally for her work developing and implementing Environment, Health and Safety Management Systems in manufacturing, research and government organizations. Further, she has been involved in ISO Standards for 20 years, including: Chairperson of the U.S. Technical Advisory Group on Environmental Management, representing the US in the negotiation of ISO Environmental Standards requirements. Former member of the ANSI-ASQ Accreditation Council overseeing the accreditation of certification bodies in the U.S. Member of the ISO Joint Technical Coordination Group task force that wrote ‘Annex SL', ISO's core management system requirements and the related guidance now used in all ISO management systems standards. Convener of ISO's international working group responsible for the 2015 revision of ISO 14001 published in late 2015. Ms. Briggs provides technical support, training and audit services (1st, 2nd & 3rd party audits) to organizations of all sizes in a variety of sectors, including certification bodies, on ISO 9001, ISO 14001, ISO 45001 (OHSAS 18001) and integrated EHS and Quality management systems. Susan L.K. Briggs graduated from Harvard University with a bachelor's degree in Natural Science, concentrating in Environmental Science and Statistics. She has numerous publications in technical journals, including authoring "ISO 14001:2015 Environmental Management System Handbook: A practical guide for Small and Medium Size Enterprises (SMEs)". She maintains a series of certifications, including: ASQ Certified Quality Auditor, Quality Engineer and Quality Manager/Organizational Excellence NREP Registered Environmental Manager PECB Certified: Trainer, ISO 9001 Lead Auditor, ISO14001 Lead Auditor and ISO 45001 Lead Auditor