Company is not FDA/ISO regulated - Limited ISO/FDA experience in Resume!

[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!

[Wes Bucey]

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.

[BradM]

Welcome to the Cove!

Basically I am in agreement with Wes. Focus on what you do know and what you have accomplished. For all you know, you may have been performing highly valuable services where you were. Just sell who you are; that's what the potential employer is interested in.

[Ajit Basrur]

Just to add on the valuable comments so far, it doesnt matter if your organization is FDA certified or not but is very important if you are aware with the FDA or ISO requirements.

During the interview, if you are asked questions on FDA / ISO and you are able to answer those, thats what the prospective employer would be looking for, isnt it ?

[confusedkid]

Our medical device is still in developmental stages and isn't sold to anyone in the market. The device goes straight to our clinical lab for their use only. I was told that as long as the device stays internally, we don't have to be FDA/ISO yet.

I'm definitely familiar with ISO/FDA regulations. I'm just worried that I may have developed bad habits and poor implementation of ISO/FDA at my current company.
Thank you to everyone for the advice. It is very much appreciated.

[Ajit Basrur]

In Reply to Parent Post by confusedkid

Our medical device is still in developmental stages and isn't sold to anyone in the market. The device goes straight to our clinical lab for their use only. I was told that as long as the device stays internally, we don't have to be FDA/ISO yet.

Thats true

In Reply to Parent Post by confusedkid

I'm definitely familiar with ISO/FDA regulations. I'm just worried that I may have developed bad habits and poor implementation of ISO/FDA at my current company.
Thank you to everyone for the advice. It is very much appreciated.

Do not get distracted; stay focussed and always be aligned with FDA / ISO regulations

[Jim Wynne]

In Reply to Parent Post by confusedkid

I'm definitely familiar with ISO/FDA regulations. I'm just worried that I may have developed bad habits and poor implementation of ISO/FDA at my current company.

In addition to the good advice so far, which boils down to "accentuate the positive," you could run into trouble getting hired without having actual experience in dealing with third-party audits. It depends on the job requirements and how well you might fit the profile otherwise.

[capriceblack]

Hi Confused Kid,

I would like an opportunity to speak with you. I am currently with a small medical device company that is in a similar situation as your current employer. They are looking for a quality manager to lead them through ISO and FDA certification process. You can reach me by email or phone # in the profile.

Thank you.
Caprice Black