Brian Bertram Email & Phone Number

As a Principal Engineer for Software in Supplier Quality, I have a very broad range of duties I am the Leader for the Center Of Excellence for Software where my team and I define training, mentoring over 150 Supplier Quality Engineers in software globally. I help define our QMS for software needs and act as an internal expert for software compliance needs across the business. From New Products Introductions, IT Systems, and new startup businesses that are working with GEHC in developing new AI Software for our products. Software, in the Medical Device arena, is a highly regulated area and requires many years of experience to know how each regulation applies to what product or IT system. I do a lot of teaching on a number of subjects from auditing, risk evaluation, Software Development Life Cycle, and IT Validation to name a few areas. Because software is one of the most dynamic and ever-evolving areas and affects almost every medical device in healthcare today. It requires a lot of reading staying current and using a lot of common sense, which is only developed over many years of experience.

Listed skills include Project Management, Management, Training, Change Management, and 8 others.