B101 - Basic Quality Management 

Instructor George Marcel

Instructor Bio

• George J. Marcel, has over 30 years’ experience in Quality Assurance Systems in multiple industries (including medical device, biotech, automotive, commercial, green tech (wind power), and other high-tech industries) as a quality professional in roles as director, manager, engineer, supervisor, and project manager.  His past non-medical industry employers include Rockwell International, Kenetech Windpower, and Sun Microsystems.  Quality implementation focus on industry compliance, customer requirements, and quality improvement tools.

• With over 15 years’ direct experience the medical device industry including multiple start-ups, George has hands on experience in implementing quality management systems and projects from initial development to implementing correction in commercial systems (that required revision due to non-compliance or other gaps including multiple FDA Warning letter responses).  George has worked on five PMA projects and multiple other product regulatory submissions.

• George is a senior member of ASQ for over 25 years as well as RAPS and many other professional organizations. George has attained multiple ASQ certifications (7) including all regulated health industry focused accreditation: Certified Biomedical Auditor (CBA), Certified HACCP Auditor (CHA), and Certified Pharmaceutical GMP Professional (CPGP).    He has served as past examiner for the Malcolm Baldrige National Quality Award (MBNQA).    Education background:  Michigan State University, Oakland University, University of Michigan – Dearborn, and University of California – Berkley.

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Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.