
Consulting Services
Work with a professional quality specialist with more than 25 years’ experience. Certified Lean Six Sigma black belt. Expertise in class I and II medical products. Proficient in ISO 13485:2016, ISO 9001:2015, AS9100 Rev D, ISO 14971:2019, cGMPs, cGLPs, and 21 CFR 820.
Extensive Quality Engineering Background
Additional Information
Professional with 25+years of both military and civilian experience. Background in Class II medical products, including nuclear grade systems, and IVD activities.
Design Control/Assurance management with responsibilities including new product development, system upgrades, and software qualifications. Direct management of complaint investigations and analysis, incoming inspection activities and quality engineering support directly related to the existing manufacturing activities.