Joseph Azary has spent the last 27 years in the medical device industry in various quality and regulatory positions. He is currently the Vice President of Quality & Regulatory at Z-Medica, LLC. Joseph has worked for US Surgical (now part of Medtronic), Johnson & Johnson, Fujifilm Medical Systems, and Sekisui Diagnostics. He was a consultant for 10 years where he worked with over 180 medical device companies around the world on a variety of quality and regulatory projects including 510k submissions, internal auditing, supplier auditing, quality system development (ISO 13485, FDA QSR), international regulatory registration and compliance, regulatory strategy, compliance, and training. Joseph has a bachelors degree in Biological Sciences and a Masters Degree in Business Administration with a concentration in Public Health. He is an ASQ Certified Quality Auditor.
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The internal audit profession is very similar to other professions; very resistant to change. When one of our profession’s main goals is to promote efficiency and effectiveness, we have to be more adept at adjusting and being open-minded to change. Audit2020 is a course that takes an in-depth look at the accepted practices inherent in internal audit and critically analyses each piece, identifying ways to en..
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An overview of how to set up an internal audit program to address quality management system standards, government regulations, risk management as well as usage for continuous improvement.This is especially useful for small to medium-sized medical device companies and start-up companies to ensure that all of the applicable regulatory requirements are incorporated into the system to ensure compliance with all..