Hi All,

I will an interview this friday. The job required that I have 2 years of FDA experiences. I have no FDA experience but I have over 12 years of ISO and TS16949 systems.

Can some tell me what is the best answer to the FDA questions?

Many Thanks.

Hi All,

I will an interview this friday. The job required that I have 2 years of FDA experiences. I have no FDA experience but I have over 12 years of ISO and TS16949 systems.

Can some tell me what is the best answer to the FDA questions?

Many Thanks.It depends.

Rather than trying to fish out some FDA answers, I would suggest that you tell them upfront about your valuable experience with quality systems and that most are generally similar. You can learn the FDA requirements as applied to ISO oe TS type systems.

Welcome to the Cove:bigwave:

Can some tell me what is the best answer to the FDA questions?

You already gave the best answer:

I have no FDA experience
:D

If they need someone with FDA experience, you won't get the job. But you can always stress your other experience and hope for the best.

Welcome to the Cove:bigwave:



If they need someone with FDA experience, you won't get the job. But you can always stress your other experience and hope for the best.

That may not be true, while the FDA is a different animal than ISO it is also very similar and they may be willing to look past the fact that you do not have any experience working in a FDA regulated enviornment if you can show them during the interview that you have a good grasp of quality systems. Check out FDA.gov and do some research before your interview and good luck.

The best policy is to be honest. Trust me they will find out that you have no FDA experience maybe not right away but it will show.


Coury Ferguson
Program/Contracts Manager

That may not be true, while the FDA is a different animal than ISO it is also very similar and they may be willing to look past the fact that you do not have any experience working in a FDA regulated enviornment if you can show them during the interview that you have a good grasp of quality systems. Check out FDA.gov and do some research before your interview and good luck.

Aaron,

Note that I said "If they need someone with FDA experience..." and went on to say that the OP should stress his experience in other areas. I've been hired in situations where I didn't have all of the listed requirements, so there's always hope, especially if there's a dearth of FDA-experienced candidates.

I agree with Jim, if a company is looking specifically for FDA experience you might not get the job. The question you need them to answer is why do they need FDA experience? Do they want someone who has been through an audit by the FDA? Do they want someone who can install systems that are acceptable to the FDA? The former REQUIRES that experience, the latter can be shown to be consistent with your experience.

I've never worked for the FDA but I have spent quite a bit of time developing SW that required FDA approval. I know that the FDA is very interested in quality processes that are documented and traceable. If you have ISO experience, you probably have a good understanding of what's involved with a quality process so that it can survive an audit. I'd recommend being honest about your lack of FDA experience but emphasize your quality process experience, assuming that's where your strength is.

Welcome, Sleepless!!!

Great first post!!!

If the job posting requires FDA experience and they still invite you for an interivew, then your experience (or lack of) is not a concern to them. They have already seen your resume (which they should be able to tell how much FDA experiences you have)! Relax and answer questions honestly during the interview(s). Advice: Instead of pointing out your shortcomings in this subject, bring up your strengths and give them examples on how you handled the challenges in the past and excelled. (Bottom line: Are you a fast learner? Can you handle it?) Good luck!