Just curious if anyone here has made a job transition from either 9001 or 13485 company into the AS9100 field. If so, how difficult was it for you? Would anyone care to share their experience? Or, maybe it wasn't 9001/13485, but another similar shift?

Considering a new career, Gidget? :notme:

I used to be butcher way back, and I found the shift in to medical devices quite challenging.... By now I am in my third MD-company, and every shift has been quite a strain, but I have grown from each and every occupation that I have held - I think? :tg:

Or, maybe it wasn't 9001/13485, but another similar shift?
I had always worked in the automotive field so I've worked with ISO, QS and the Big 3 specific stuff - Pentastar, TFE, Q1 - prior to those. It wasn't until I had been working here for a few years that they decided to get into the military and aerospace market.

I had absolutely no aerospace experience so I bought the standard and started reading. I talked to as many people as I could and I asked questions - here, my registrar's technical manager, customers, suppliers... - and I googled my brains out. I spent a lot of time on the SAE website.

I learned alot from our customers too because we had to go through so many customer audits before we became AS9100 registered. That was probably what I benefited most from. I found that most of the SQAs that audited us were more than happy to show me how smart they are :D so I asked all kinds of questions about AS9100 requirements while they were here.

Since I was currently employed and they wanted me to champion the AS9100 implementation, they had to provide the resources I needed to educate myself and then educate everyone else. If I had no aerospace experience and wanted to go work somewhere aerospacey then I would probably have had a little harder time.

Moved?? I'm doing all three at the same time! (ISO9001, AS9100, ISO13485)

Actually most of my experience within the company has been with aerospace. Medical devices here has only been added over the last half dozen years or so. While my company is currently registered to ISO9001, I am trying to implement AS9100 and ISO13485 at the same time. (Ain't that fun considering upper managment can't even spell AS9100 or ISO13485 much less understand what is required. :bonk:)

I just recently completed a gap analysis for both systems and to my surprise there seemed to be less gaps to fill for ISO13485 than for AS9100. We are a contract medical device manufacturer so we don't have to deal with such things as user recalls or 510k's and luckily no implantible devices.

While there definitely is a lot of information and regulations to process for medical devices, I feel there is also a lot of pressure knowing that you have the FDA and other regulatory agencies looking over your shoulder (as well as they should be seeing medical devices deal with human life).

With the aerospace industry, I don't feel quite the same, strong paranoia of having somebody looking over my shoulder. Maybe it's just me, or the fact that I'm not directly building aircraft, or that I have more aerospace experience (although I have found there is always more knowledge to gain). Granted there are still FAA requirements but it just doesn't feel the same.

That's my :2cents:.