RABQSA or IRCA or CQA (Certified Quality Auditor) - Biomedical

C

chigga

#1
I am a young QA specialist in an ultrasound company, and I have been working there for 3 years. I want to add some expertise to my resume, so I passed the CQE in June this year on my first try, however, it is turns out my job has nothing to do with manufaturing, so there is no chance for me to practice what I learned from preparing CQE exam.

For my next certification, I want to have a well recognized certification and also I want the certification can help with my daily work. So there is a chance:

This year, my company product is changing from pre-clinical to clinical use, which means we have to get certification for ISO9001 and ISO13485, and we have to pass FDA, too. My company has been an ISO9001 registered company for years, but the ISO13485 will be new this year, and FDA will more strict than before.

Currently, our QA manager is doing all the certifation stuff along, and he definitely need help as I can tell.

I would like to have some auditor certification specialized in medical device area. I found 3 orginazations provide auditor certifications, and which one should I take?

RABQSA or IRCA or CQA-Biomedical

Eventually, I would like to be a person who can help companies in biomedical area to get certified, I do not know I should take internal auditor certification or I should take 3rd party auditor certification.

What I am thinking is the 3rd party auditor certification sounds like a higher level of the internal auditor certification, what I mean is, I would assume the person who holds 3rd party auditor certification will be able to do what the person who holds internal auditor certification can do, but the internal auditor can not do what a 3rd party auditor can do. Am I right?

Summary of my question:
RABQSA or IRCA or CQA-Biomedical?
internal auditor certification or 3rd party auditor certification?

Thanks!
:eek:

 
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Randy

Super Moderator
#2
Re: RABQSA or IRCA or CQA-Biomedical

Normally to get any level of certification other than the basic level you have to have experience...and you have how much and what kind?

Oh, forget the 3rd party certification unless you have actually done it.
 
C

chigga

#3
Re: RABQSA or IRCA or CQA-Biomedical

Randy, thank you for your reply.

I just attend company internal audit before, i.e., I was internal audited by our QA manager, he asked me questions, and I also prepared daily doc control, supplier qualification surveys, and nonconforming product analysis for him. That is all my experience about audit.

Actually this is my first job.
 

Randy

Super Moderator
#4
You have established a pretty good goal for yourself...Honestly, here's what you need to do.......Get a few years of experience under your belt and get that experience in multiple fields.....Until you can say "Here is what I have done, seen and experienced..." you're not going to be given much credence as an auditor, especially by old geezers like me and many others.
 
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