Breaking into quality management in an FDA environment

[WWilliams]

Hello all, sorry if this is somewhat off topic. I have a lot of years in Quality Mangement, but my experience with GMP is limited to some exposure 15 years ago. I wish to break into quality management in an FDA environment.
What advise would you give me?
Incidently, I am degreed (BS-Org Mgmnt), a CQE, CQA and have extensive automotive background.

 

[lisansd99]

Hi
I am going through a similiar process and have had positive response with my job search because of focusing on the skills/knowledge/abilities versus my job title. Focus on what you have done and learned! Sounds like the "breaking" has begun and now it's time for soul searching.

What job target are you trying to "break" into? What type of company? What type of job? Why? How does that compare with what you are doing today?

I would recommend networking and meeting with either other collegues that are in your target job market, see what issues these companies are having and how your skills compare. For instance - I dealt with compliance mostly with my last position, saw another company's goal was wanting ISO certification in the future and contacted the hiring manager showing that I had skills in complaince and showed how they aligned with the requirements with ISO (making long story - very short).

I have been following a certain methodology for my job search and will gladly provide you the website and/or any information if wanted.

Here is to continued success in your job career and know that you will do well! May you get many meetings.

Lisa

 

[LMU23]

If you haven't already, I suggest that you consider taking some courses on FDA regulations. Depending on where you are located, either ASQ or RAPs may have something to offer. We have hired Engineers without medical device background and we viewed it positively if they had taken such classes. In our area, it is quite common for individuals to seek out the medical industry when high tech is in a slump. If they have made the effort to seek out additional education it can set you apart.

Some QA positions deal more with the day to day activities in manufacturing. I think these might be easier to break into than a position that is heavily compliance related.

Good luck.