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. |
 |
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 600+ audits for
registrars and clients, mostly 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 by the International Registrar of
Certificated Auditors (IRCA), ASQ Certified Quality
Auditor (CQA), Medical Device Lead
Auditor (MDSAP: ISO 13485, FDA, Health
Canada, MDR, 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 |
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.
|
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. |
 |
|
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, 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. |
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, CSertified
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
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
600 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 certified Lead Auditor (AS9100,
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. |
|
|
|