Jack Ward, CQM, CSQE

Senior Director

Jack Ward has more than 25 years of experience working with quality, compliance and R&D at a wide range of medical device companies. Jack spent more than 10 years in quality at Affymetrix in Bedford, MA. For the last few years, Jack has been running his own solo consulting practice, working with both entrepreneurial ventures and larger clients, such as Applied Biosystems.

He has worked extensively in product development, managing large engineering teams distributed in the U.S. and Europe. Jack also has extensive medical device Quality Assurance and Regulatory experience, with past worldwide management responsibilities. He has been responsible for developing and implementing FDA and ISO compliant Quality Systems and has successfully hosted multiple FDA inspections and ISO audits. Jack has taught engineering courses at the university level and conducted numerous industry-level Quality and Regulatory courses.

Jack earned his MS in Computer Science at Boston University. He is a Certified Quality Manager (CQM) and Certified Software Quality Engineer (CSQE). Jack is also an active faculty member of the Association for the Advancement of Medical Instruments (AAMI), where he teaches courses on QSR and Design Control.

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Recent Blogs

Great New Companion Diagnostics E-Book Released Today A valuable resource in a hot, but under-informed segment of the market
Oragene Clearance Shows DNA Stabilization is Class II Clearance could have a significant impact on DTCG providers
My Screening Test for Screening Tests Offering up a rare bit of regulatory certainty
The Abolish OIVD Act of 2011 A torches-and-pitchforks approach to LDT regulations

Glossary Terms

Design Control
International Organization for Standardization (ISO)
Quality
Quality System
Quality System Regulation (QSR)