Course offering number:1204-204
Course ID:
2481
Managing Purchasing Controls for Medical Device Companies
April 11, 2012
New Brunswick, NJ
John Freije; President and Principal Consultant, Freije Quality Engineering, LLC
John Freije works with medical device companies and their
suppliers to develop and implement Quality Systems that
exceed the expectation of ISO 13485 and FDA's Quality
System Regulation 21 CFR 820.
Mr. Freije has over 28 years experience working for the
government and the private sector, with 18 years in the
medical device and pharmaceutical industry. Experience
includes working in quality systems at Roche Diagnostics as a
Quality Systems Principal, Product Assurance Manager for
Raytheon Technical Services Company involving projects for
the Special Forces and Direct Fire Control, Engineering and
Quality positions at Eli Lilly and Company focusing on bulk
manufacturing for injectables and dry products manufacturing
for clinical trials, medical device commercialization and
manufacturing. He served eight years in the Ordnance Corps
in the US Army as a Systems Mechanic.
Mr. Freije received his Masters of Science in Engineering from
the University of Wisconsin and completed his undergraduate
studies at Purdue University. He is a senior member of the
American Society for Quality (ASQ) where he is a Member
Leader in the Biomedical Division and active with the Society
of Manufacturing Engineers (SME). Mr. Freije is also an ASQ
Certified Quality Engineer and a SME Certified Manufacturing
Technologist.
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