Orion Canada Inc.
     
Orion Canada Inc.  
 
      Consulting Auditing Outsourcing
   
       
   
 
   
   

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 founder of Orion Canada Inc., is a certified IRCA 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 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.

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 often performs audits of mission critical systems and organizations (aerospace, medical, defense, software, IT, security, regulatory, etc.).

His auditing credentials include: Certified Information System Auditor (CISA) by the Information Systems Audit and Control Association (ISACA), QMS Lead Auditor and Information Security Management System (ISMS) Auditor by the International Registrar of Certificated Auditors (IRCA), ASQ Certified Quality Auditor (CQA), Medical Device Lead Auditor and Health Canada CMDCAS Auditor for medical devices. 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.

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.

Mary Jo, Management System Consultant

Mary Jo is an experienced quality system leader, auditor and project manager and with a strong background in manufacturing and medical devices.


Mary has worked within organizations registered to ISO 9001, ISO 13485, and ISO/TS 16949 standards where she has planned, documented and managed quality systems, and led the corrective & preventive action, and internal audit functions. She is also skilled in risk assessment, process planning, and continuous improvement for quality and environmental systems.

Mary is a graduate of Mechanical Engineering at Queen’s University and is a member of the Professional Engineer’s of Ontario and the ASQ. She is a Professional Engineer (P.Eng.) and a Certified Quality Auditor (CQA). Mary is based in Ottawa, Ontario.
 

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

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.

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.

Doug Stowe P.Eng., Environmental & OHSAS Consultant

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.

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, Director of Quality at SMART Technologies Inc., Product Assurance Manager at COM DEV Space Systems, and a Quality Management Project Leader 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, Certificate in Quality Management and has IRCA QMS Auditor and Aerospace Provisional Auditor certifications.

Hien Nguyen, Aerospace Software/DO-178B & DO-154 Consultant

For more than 20 years, Hien has assisted mission critical companies in the telecom, aerospace and defense industries with quality system implementations, audits and business improvements.

Hien's expertise includes design assurance for DO-254 mission critical hardware and DO-178B for mission critical software. She has assisted many organizations in establishing quality systems for new organizations to achieve ISO 9001 and AS9100 certifications. As an experienced auditor, she has lead and conducted many ISO 9001, AS9100, DO-254 and DO-178B compliance audits.

Hien has more than 20 years experience in quality system implementation, audit and business improvements in mission critical companies in the telecom, aerospace, and defense industries.

Her quality accreditations include American Society for Quality (ASQ) Certified Software Quality Engineer (CSQE), ITIL (IT Service Management Foundation), SPICE/ISO 1554 assessor, TickIT (software) Lead Auditor,  and DO-154 & DO-178B trained Project Leader.

Sheila Peckford, Healthcare/Medical Device Consultant

Sheila has over 25 years of experience in the healthcare and regulatory & quality management fields, both nationally and internationally.  Her quality management and auditing credentials include: Certified Quality Auditor (CQA) with ASQ, Certified Manager of Quality/Organizational Excellence (CMQ-OE) with ASQ, Certified Professional Healthcare Quality (CPHQ) with the US National Association for Healthcare Quality and ISO Lead Assessor (RAB/IRCA Accredited Training).

Ten years of regulatory and performance management experience with Canadian Blood Services has provided Sheila with expertise in conducting audits and operational assessments in such disciplines as blood and blood products collections (including stem cells and bone marrow), reference and testing laboratories and blood banks.
As an auditor, Sheila has conducted numerous multi-site audits in the pharmaceutical, biologics manufacturing and medical devices fields, both nationally and internationally.

As a consultant in the medical devices field Sheila has supported organizations in implementing corporate wide quality management systems and successfully achieving registration to ISO 13485:2003. Throughout her healthcare career, Sheila actively participated in the implementation of healthcare accreditation programs and standards in facilities throughout Canada and beyond (Saudi Arabia and the United Arab Emirates).

As a Quality & Risk Management professional, Sheila has held postings as the Director of Quality and Quality Specialist and successfully supported the implementation of strategic corporate Quality and Risk Management programs in healthcare facilities in both Saudi Arabia and the United Arab Emirates.

Anne Senior, Facilitator and Technical Writer

Anne is a professional facilitator, consultant, trainer and technical writer. She has more than 20 years of experience. Her significant expertise includes course development, course instruction, testing, technical writing, project management and quality control.

Anne has helped many clients achieve considerable success. She has delivered training to Canadian government, United Nations, and private sector clients including Atomic Energy Canada, JDS Uniphase, Nortel Networks, and Syncrude Canada. She has provided language training, cross-culture and technical writing courses. Anne is accredited as a "language expert" by the Centre for Canadian Language Benchmarks; she is Canadian Language Benchmarks Placement Test assessor; she is currently field testing the Literacy Placement Tool and is on the National Advisory Committee for the Enhanced Language at Work Project.

Sam Weissfelner, Aerospace & Security Auditor and Trainer

Sam Weissfelner is a quality professional with over 20 years of experience in Systems and Software Quality Assurance in the Aerospace, Software, Telecommunications, and Military fields. As a certified Aerospace Industry Experienced Auditor (AIEA), he is fully qualified to lead registration audits to the latest AS9100B Aerospace standards.

Sam is also a completely certified TL9000 (Requirements & Measurements) Release 4.0 auditor and Subject Matter Expert, who contributed to the development of this global Telecommunications standard. In addition, he performed the first registration audit in the world to TL9000, and helped numerous other organizations attain certification to this demanding Telecom standard.

Having conducted over 500 Quality 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 RAB-certified Lead Auditor (AS9100, ISO 20000, ISO 27001 and TL9000). He also develops and conducts Quality Management training programs, and continues to support the development of high reliability mission critical software systems.

 
 
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