Copyright © 2010 All rights reserved Freije Quality Engineering, LLC
Veteran Owned Business
John Freije, CQE, CMfgT is the President and Principal Consultant at Freije Quality Engineering, LLC. In this capacity John works with medical device companies and suppliers to medical device companies to develop and implement Quality Systems that exceed the expectation of ISO 13485 and FDA’s Quality System Regulation 21 CFR 820.
John brings to the table over 30 years experience working for the government and the private sector, with over 20 years in the medical device and pharmaceutical industries. John has held several positions with increasing responsibility at Roche Diagnostics, Eli Lilly & Co., Raytheon Technical Services, and the US Army.
Developed and implemented supplier audit program
Successful commercialization of a new insulin pen-injector
Led Design Controls effort for new infusion pump selectable flow controller, including Human Factors evaluations and 510(k) preparation, which resulted in a successful launch three months prior to plan
Provided quality assurance for an insulin combination product
Successful implementation of ISO 13 485 compliant quality systems for medical device suppliers
Provide ongoing Process Validation guidance/support to a plastic injection supplier to the orthopedics industry
Conduct sterile barrier packaging validations
Leading companies through Notified Body audits and FDA inspections