P.Eng., CQE, CQA
Member of the Ordre des Ingénieurs du Québec, the American Society for Quality and the Quebec Society for Quality, Ms. Blain has been working in the manufacturing and services industries since 1989, and in quality management & assurance since 1993, and specifically in the automotive industry since 1995.
She is a "Certified Quality Engineer" (CQE) and "Certified Quality Auditor" (CQA) by the ASQ. She holds a certification in "Lean Manufacturing" from Michigan University and the "Exemplar Global-Certified ISO 9001:2015 Lead Auditor Training with AIAG IATF 16949:2016 Supplier Auditor Certification."
Ms. Blain has amalgamated many years of experience in the implementation and audit of processes, and in the optimisation of management systems, to ensure that they are an added value to the business.
Graduated from the Concordia University in Montreal where she obtained a bachelor degree in chemistry. She has worked for 30 years in chemistry and microbiology laboratories in the pharmaceutical, food and medical devices industries where she had to set up and implement quality assurance programs to meet the requirements of the Health Protection Branch and USFDA. She has practical experience with implementation of ISO 9001, ISO/IEC 17025 and ISO 13485, and has worked as a consultant for the pharmaceutical, food and medical devices industries. She specializes in ISO 9000, ISO/IEC 17025, ISO 13485; she successfully passed the CMDCAS exam as well as the European Notified Body exams. She is lead auditor certified by IRCA and has performed many audits on behalf of a CMDCAS and CE Marking recognized registrar. She established her own consultation firm to help the industry in implementing quality management systems through quality audits and practical recommendations.
Metallurgical Engineer with a Master and a Doctorate in Applied Sciences, he enjoyed a long career with Hydro-Quebec and is now President of Accademia Qualitas.
Involved since 1972 with national and international standardization, he chaired a number of National committees for the Canadian Standards Association (CSA) and the Standards Council of Canada (SCC). From 1997 to 2003, he was also International Chairman of ISO/TC 176, the committee responsible for the ISO 9000 standards.
He also chaired the International Standardization Committee which developed the ISAS BCP 9001 Standard for the Media, the “Association Québécoise de la Qualité” and the “World Council for Quality – A Network for Sustainable Management Systems”.
Certified lead auditor and Site examiner for the Canada Awards for Excellence, he received over the years a number of National and International Awards for his leadership in the field of Quality.
Graduated from Laval University in Quebec City as a bachelor in Mechanical Engineering. Since 1991, he has acquired a solid experience in Quality management systems (QMS), Environmental Management systems (EMS) as well as OHS Management systems. Over the years he has been involved in more than 200 projects in different organizations. He has specialized in the improvement of business processes as well as the implementation and integration of Quality Management Systems (ISO 9001), Environmental Management Systems (ISO 14001) as well as Health and Safety Management Systems (OHSAS 18001).
He is an ISO 9001 lead auditor (quality), an ISO 14001 lead auditor (environment) as well as an OHSAS 18001 auditor (Occupational Health & Safety). He is also involved with the “Grands Prix québécois de la qualité”, where he acts as an Expert in the evaluation of organizations. Finally, he has taught Quality Management at the “École de Technologie Supérieure” at the university bachelor degree level and provides contract services to different management system registrars.
|Industrial Engineer, member of Order of Engineers of Quebec, she holds
- a Black Belt certification from the American Society for Quality (CSSBB),
- an Aircraft Certification Speciality Course from Transport Canada and
- a Master in Management Engineering. She has 20 years of experience in various manufacturing environments (automotive, aerospace - civil and military, ...). Trainer and consultant (quality tools, LEAN) and experienced auditor (internal audits, suppliers and special processes) in the aerospace and automotive sectors (Canada, USA, Mexico and Asia).
Graduated as an industrial engineer, she has worked for more than fifteen years with small, medium and large companies in the implementation and improvement of quality management systems according to ISO 9001, in training and in audits.
She also performs audits for a registrar that is accredited by the Standards Council of Canada. She is qualified to audit many sectors such as pulp and paper, printing, chemical industry, metallurgy, metal, distribution, information technologies and professional services.
She also has, over the last 15 years, developed a recognized expertise in the implementation of ISO/IEC 17025 in various types of laboratories. She helped many laboratories obtain their accreditation by the Standards Council of Canada.
Egan retired in 2015 after a 30-year career at Health Canada. The last 20 years were spent at Health Canada’s Medical Devices Bureau where he assisted medical device manufacturers to understand and comply with the licensing requirements of the Canadian Medical Devices Regulations. While at the Medical Devices Bureau he actively participated as a Canadian regulatory representative and quality system expert on Study Group 3 - Global Harmonization Task Force, and Working Group 1 – ISO/TC 210, to design and write the 2003 and 2016 versions of ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.
During his time at the Medical Devices Bureau he routinely worked with regulatory counterparts from Canada’s main trading partners and developed extensive knowledge and experience with the United States, Code of Federal Regulations (CFR) 21 Part 820 quality system regulations, the European Medical Device Directive (MDD 93/42/EEC), European Active Implantable Medical Device Directive (AIMDD 90/385/EEC) and the medical device regulatory requirements of Australia, Brazil, and Japan.
While at the Medical Devices Bureau, Egan was part of a team of experts that developed, implemented and managed the Canadian Medical Device Conformity Assessment System (CMDCAS) and participated as a Canadian subject matter expert on an international team that developed the Australia, Brazil, Canada, Japan and US Medical Device Single Audit Program (MDSAP) which is scheduled to replace CMDCAS on January 1, 2019.
Currently Egan provides training, auditing and consulting services to medical device manufacturers, suppliers and an international non-government organization.
Egan obtained a Master of Science degree in analytical chemistry (1990) from Queen’s University, Kingston, Ontario and a Bachelor of Science degree in radio-chemistry (1983) from Carleton University, Ottawa, Ontario.