In Reply to Parent Post by confusedkid
Hi Everyone. My company is divided into two sections: (1) a medical device manufacturing company exclusively for the (2) CLIA certified clinical lab. My company is not FDA reg or ISO certified and we are striving to obtain certification but I fear it won't be completed for awhile. We have some systems in place but not all. I've been here for 3 years. I have a total of 4 years of experience in quality and I've taken ISO 13485 training classes. If I look for another job, will it hurt me that my company is not FDA/ISO regulated? What can I write in my resume? Thanks!
I'm confused. Aren't ALL medical device companies subject to FDA regulation, either directly, or as a supplier to an FDA-regulated company?
In answer to your direct question- the primary question in a new employer's mind will be, "What can you do for us?"
Therefore, you will stress your skills and knowledge and how they will apply to the new employer [I presume you mean an employer who is registered with either or both FDA and ISO.]
If you are not currently dealing with FDA or ISO Standards, you will need to show you are at least familiar with them and how your other work experience in dealing with documentation and paperwork will give you a leg up on dealing with the FDA and ISO prescribed documentation without messing up.