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                       Consultant Profiles  
                      Orion Canada’s success is the
                        result of the industry’s best consultants working
                        together to deliver significant value to its clients.
                        When you partner with Orion Canada Inc., you
                        engage a team of experts. Below are brief profiles of
                        some of our consultants. 
                        
                      
                        
                        
                          Joe
                              FitzGibbon, President, Orion Canada Inc.  | 
                         
                        
                          Joe
                            FitzGibbon, President and co-founder of Orion Canada
                            Inc., has 20+ years of experience as a certified Lead Auditor and ISO
                            9001, ISO 14001 and ISO 13485 consultant, specializing
                            in management best practices and regulatory compliance.
                            Joe has over 25 years as a quality system consultant,
                            auditor and trainer, and holds the highest certifications
                            in those fields. He is an accomplished author 
                          on international medical device regulations and
                            a highly sought after speaker at conferences. Prior
                            to founding Orion Canada, Joe spent several years
                            in the Canadian Federal Government, 
                          holding executive level positions in 
                          management, regulatory and consulting 
                          environments.  | 
                          
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                          Chris
                                FitzGibbon, Vice President, Orion Canada
                                Inc.  | 
                         
                        
                          Chris
                            FitzGibbon has led numerous “break-through” process
                            improvement projects in mission critical industries
                            including IT/software, telecom, aerospace, 
                          defense, engineering,
                            government, manufacturing and service sectors.                              Chris is an American Society
                                for Quality (ASQ) Certified Manager of Quality/Organizational 
                          Excellence (CMQ-OE)
                                and a Certified Software Quality Engineer (CSQE).                              
                          Chris has performed 1000+ audits for 
                          registrars and clients, mostly of mission 
                          critical systems and organizations 
                          (aerospace, medical, defense, software, IT, 
                          security, regulatory, etc.).  | 
                          
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                           His
                            auditing credentials include: Certified Information
                            System Auditor (CISA) by the Information Systems
                            Audit and Control Association (ISACA), QMS Lead Auditor  by the International Registrar of
                            Certificated Auditors (IRCA), ASQ Certified Quality
                            Auditor (CQA),  Medical Device Lead 
                          Auditor (MDSAP: ISO 13485, FDA, Health 
                          Canada, MDR, UKCA, etc.). Chris also has extensive experience 
                          consulting with standards such as ISO 9001, 
                          ISO 13485,  AS9100, ISO 27001 and 
                          others. 
                            He
                                
                                represented Canada on the ASQ Software Division’s
                                regional council for seven years. And, Chris was awarded the
                                prestigious International
                                Quality Award - Feigenbaum Medal for outstanding
                                achievement and recognition of his contribution
                                to software quality improvement and 
                            work with the Canadian and European space 
                            agencies. 
                            Chris
                                is the co-author of the book “ISO 9001 Registration for Small and
                              Medium Sized Software Enterprises” (McGill-Queens
                              Press, 1995) and published the Masters thesis “An
                              Analysis of the Differences in Software Project
                              Management Practices Between Organizations Registered
                              to ISO 9001 and Non-Registered Organizations” (Carleton
                            University, 1998). Chris is based in 
                            Ottawa (Stittsville) Ontario. He is a 
                            co-founder of Orion Canada.   | 
                           
                       
                      
                        
                          
                          Mary Jo, Management System 
                          Consultant  | 
                         
                        
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                            Mary is an experienced project manager and 
                            quality system leader with a particularly 
                            strong background in manufacturing, 
                            medical devices and service delivery.                               
                            She has worked within 
                            organizations registered to ISO 9001, ISO 
                            13485, ISO 17025, and TS16949 standards 
                            where she has set up and managed quality 
                            systems, and led the corrective & 
                            preventive action, and audit functions. 
                            Mary has led internal audits, supplier 
                            audits, and represented organizations 
                            through successful third-party audits for 
                            the ISO 9001: 2015 requirements, ISO 
                            13485:2016 requirements, and MDSAP. She is 
                            also skilled in risk assessment, process 
                            planning, project management, and 
                            environmental system management.  
                            Mary graduated from 
                            Mechanical Engineering at Queen’s 
                            University and is a member of the 
                            Professional Engineers of Ontario. She is 
                            a member of the American Society for 
                            Quality. She is a certified quality 
                            auditor (CQA), and has earned course 
                            certificates for ISO 9001, ISO 13485:2016, 
                            MDSAP, Quality system audits, and 
                            Environmental system audits. Mary is a 
                            certified ISO 9001 Lead Auditor (PECB LA). 
                            She is based in Ottawa, Ontario. 
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                          Veronica Marquez, Business Transformation 
                          Consultant and Trainer  | 
                         
                        
                         
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                            Veronica Marquez is a multilingual supply chain and operational excellence consultant and trainer with more than 25 years of experience. She has worked in omnichannel distribution in a CPG organization, B2B distribution services, municipal operations, and with small and medium size organizations. 
                            Veronica is known for her inclusive approach where she involves the entire organizational community in creating the vision of the future, exploring avenues for optimization, and co-developing the elements necessary to achieve her client’s business goals. She works on developing and aligning the strategy as well as implementing the tactical improvements and education required for success.                             
                              
                            Veronica graduated from Concordia University with a BA in Political Science and HEC Montreal with a M.Sc in Operations Management. She is a certified Lean Six Sigma Black Belt from the American Society of Quality. She also volunteers in the leadership teams of ASQ Montreal and the Réseau des femmes d’affaires du Québec in Montérégie.  In 2023, she was named one of the Top 50 Experts to follow in Operational Excellence by the PEX Network. She is based in the Montreal area. 
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                          Mike de van der Schueren, 
                          Management System Consultant  | 
                         
                        
                          
                          Mike's expertise is built on more than 25 
                          years of hands-on experience in quality 
                          assurance and regulatory affairs in the 
                          medical, nuclear, automotive and 
                          manufacturing industries. He has designed, 
                          implemented, managed, audited and improved 
                          management systems that comply with the some 
                          of the strictest medical device, 
                          environmental, health & safety and nuclear 
                          safety standards and regulations. From 
                          troubleshooting problems on the production 
                          floor, to defect prevention through SPC, 
                          Mike always brings a process improvement 
                          approach to achieve project success and 
                          return on investment.                             
                          Mike earned his Bachelor of Science in 
                          Mechanical Engineering from the University 
                          of Waterloo. Mike is a certified auditor (CQA), 
                          a medical device (ISO 13485) auditor, and an 
                          Information Security Management System 
                          (ISMS/ISO 27001) auditor. Mike is based in 
                          Ottawa (Stittsville) Ontario.                               | 
                          
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                          Stephen
                                Davies, Management System Architect  | 
                         
                        
                          Stephen
                              Davies M.Sc., AIQA, CMQ-OE is a graduate of the
                              University of Wales College Cardiff (UWCC). He
                              gradated in 1991 with a B.Sc. (Hons) in Physics
                              with Music (Sound Engineering), and then went on
                              to graduate with an M.Sc. in Systems Engineering
                              from UWCC in 1992. 
                               
With well over a decade of industrial experience in Quality Assurance, Industrial
Engineering, Supply Chain Development, Manufacturing                               | 
                          
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                          Engineering,
                                Project Management and Strategy Development,
                                Stephen Davies brings a charismatic and dynamic
                                quality to his work. Trying to both inspire people
                                and to encourage conceptual thinking.  
                            An
                                active member of both the American Society for
                                Quality (ASQ) and the Institute of Quality Assurance
                                (IQA) he is always at the forefront of new developments,
                                and is constantly aiming to research, publish
                                articles and to deliver papers to conferences.
                                In addition to his consultation role he also
                                lectures at the Sprott Business School at Carleton
                                University (Ottawa) and is a technology agent,
                                representing Silicon foundries and design groups
                            in North America.  | 
                         
                       
                      
                        
                          
                          Peter Pringle, Software/Medical 
                          Device Regulatory Consultant  | 
                         
                        
                          
                           Peter Pringle leads Orion's European 
                          consultancy. Peter is a UK-based consultant 
                          and certified medical device auditor with 
                          international hospital experience. He has 
                          managed large scale medical product projects 
                          (e.g., installations), implemented quality 
                          systems, and overseen software development 
                          projects. His medical background combined 
                          with his software experience brings a unique 
                          understanding of the quality systems, 
                          configuration control and efficient medical 
                          device compliance.                               | 
                          
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                          Peter is a certified and active medical 
                          device auditor specializing in ISO 13485, 
                          ISO 14971, ISO/IEC 62304 and FDA pre-audits. 
                          Through his work with Notified Bodies, he 
                          has reviewed numerous technical files. He 
                          has prepared technical documentation 
                          packages for regulatory submissions as well 
                          as having professionally guided many 
                          companies on efficiently preparing their 
                          regulatory submissions. Peter has developed, 
                          worked with and evaluated software 
                          development methodologies, including 
                          procedures and documentation. 
                            From 1986 to 
                            2000 he worked in the Radiotherapy 
                            division of Philips Medical Systems 
                            (purchased by Elekta of Sweden) whose main 
                            products consist of a range of computer 
                            controlled linear accelerators for the 
                            treatment of cancer. After many years in 
                            the medical industry working in hospital 
                            environments, Peter became a consultant 
                            (Accredited Business Link & MHRA) in 2000. 
                            Since then, he has worked extensively in 
                            Scandinavia, Germany, Italy, Russia, USA 
                            and Great Britain, and for Orion clients 
                            in North America and Europe.  
                            Peter contributes a very personal view of 
                            project processes, interpretation and 
                            implementation to any forum, together with 
                            a unique ability to focus a team on the 
                            objectives and goals that are required by 
                            the sponsor of the project. His leadership 
                            skills create focus, vision and motivation 
                            at all levels of a team. 
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                          Doug Stowe P.Eng., Environmental & 
                          OHSAS Consultant  | 
                         
                        
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                          Doug has more than 20 
                          years of chemical process engineering and 
                          manufacturing engineering experience. He has 
                          assisted numerous manufacturing companies 
                          throughout the Ottawa region with their 
                          environmental and health & safety compliance 
                          and due diligence.                               
                          Doug began consulting 
                          in 2002 and has worked on Orion Canada’s 
                          largest environmental management and OHSAS 
                          projects. He has overseen environmental 
                          management programs (ISO 14001), safety 
                          management systems (OHSAS 18001 / CSA 
                          Z-1000) and performed Pre-Start Health and 
                          Safety Reviews for new or modified equipment 
                          installations. He has performed management 
                          system audits as well as compliance audits 
                          for integrated environmental and safety 
                          management systems. 
                          Doug is a licensed and 
                          insured Professional Engineer (P.Eng.) in 
                          Ontario and is also a Certified Hazardous 
                          Materials Manager (CHMM) through the 
                          Institute of Hazardous Materials Management 
                          (IHMM) in the United States.  This 
                          American designation is also federally 
                          endorsed by the CESB (Certified Engineering 
                          Specialty Board) in the United States. Doug 
                          is a lead auditor for ISO 14001 certified 
                          through RABQSA. 
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                          Daniel LeBlanc, Consultant, Auditor and 
                          Professional Trainer   | 
                         
                        
                          
                           With 
                          more than 20 years in quality, Daniel is an 
                          exceptional, senior Quality Management 
                          professional whose experience covers all 
                          sides of the quality industry. This includes 
                          implementing and maintaining business 
                          management systems from within world-class 
                          organizations, carrying out third-party 
                          audits for international registrars, and 
                          providing consulting and training services 
                          to client companies. Dan has worked as an 
                          Air Weapons Director & Computer Systems 
                          Analyst at the Department of National 
                          Defence (DND Canada), a Manager of Quality 
                          Assurance at Lockheed Martin Canada, Product 
                          Assurance Manager at Com Dev Space Systems, 
                          and a Quality Management Lead for the DND 
                          Land Software Engineering Center through 
                          ADGA Consulting Group. He has instructed 
                          hundreds through professional training 
                          courses on quality management standards and 
                          auditing. He holds a degree in Mathematics 
                          and is a certified Aerospace Industry 
                          Experienced Auditor (AIEA) and Probitas QMS 
                          Auditor.  | 
                           
                     
                       
                      
                        
                          Sam
                                Weissfelner,
                              Aerospace & Security Auditor and Trainer   | 
                         
                        
                          
                           Sam 
                          is a quality professional with over 25 years 
                          of experience in Systems and Software 
                          Quality Assurance in the Aerospace, 
                          Software, Telecommunications, and Military 
                          fields. He is a consultant, trainer and 
                          certified auditor to several standards, 
                          including the latest version of the ISO 
                          27001. Sam has worked with ISO 27001 since 
                          its inception over 15 years ago and is also 
                          familiar with BS 7799 – Information Security 
                          Management, CAN/CSA Q830 – Canadian Code for 
                          the Protection of Personal Information, and 
                          the new GDPR requirements (released by the 
                          European Economic Community on May 25th, 
                          2018). 
                            
                          In addition to information security auditing 
                          and consulting, Sam also works with the CMMI 
                          assessment model, and he is a certified 
                          Aerospace Industry Experienced Auditor 
                          (AIEA), leading registration audits to the 
                          latest AS9100D Aerospace standards. 
                            Having conducted over 
                            1000 Management System
                              audits in Canada, United States, Asia, South America,
                              Europe and the Middle East, Sam has helped a remarkable
                              number of organizations to improve their business
                              processes. He is an ASQ Certified Software Quality
                              Engineer (CSQE), Certified Quality Auditor (CQA),
                              and certified Lead Auditor (AS9100, 
                             
                            ISO 27001 and TL9000). He also develops
                              and conducts Quality and Information Security Management training programs,
                              and continues to support the development of high
                              reliability mission critical software systems.                                                          | 
                         
                        
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