What is a Quality Engineer? What does a Quality Engineer do?

M

medic61

I was told in late 2010 that I would finally get some help in the Quality department. I am in my late 50's and its time the company let me start training someone on the basics. I have been with this medical device company for 18 years and have so much to share.
The Dir of Ops has got it in his head that we need a Quality Engineer because there is so much data that we don't trend. The company Pres. is on my side and wants me to train someone.
I don't see a QE wanting to help with the basics such as auditing or doc control.
So what does a Quality Engineer do in other companies?
Thanks,
Medic
 

bobdoering

Stop X-bar/R Madness!!
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Re: What is a Quality Engineer?

This may sound trite, but the answer is anything. Depends on the work that needs done and the resources available. You need to look at the work that needs to be done, separate into meaningful sub-areas, and divide them up. Pareto and prioritize. As quality engineer I have done the same work that I have done as quality manager in other firms.
 
M

medic61

Re: What is a Quality Engineer?

So basically if I had taken the time to take the training and test I would be the QE? I handle everything we do, including process returns and all regulatory issues, but our company is growing so fast I can't meet some of my personal deadlines.

Do you think the Dir of Ops just needs a statistician instead of a QE to get the data entered, trended and monitored?
Medic
 

qusys

Trusted Information Resource
Re: What is a Quality Engineer?

I was told in late 2010 that I would finally get some help in the Quality department. I am in my late 50's and its time the company let me start training someone on the basics. I have been with this medical device company for 18 years and have so much to share.
The Dir of Ops has got it in his head that we need a Quality Engineer because there is so much data that we don't trend. The company Pres. is on my side and wants me to train someone.
I don't see a QE wanting to help with the basics such as auditing or doc control.
So what does a Quality Engineer do in other companies?
Thanks,
Medic

Quality engineer can do internal and supplier audit, manage quality methodologies ( FMEA, Problem solving , Control plan, Benchmarking,SPC, MSA etc...), make training on quality matter and support organization in implementing QMS with ISO TS , 9001 certification.
Quality eng can also manage product quality with customers.:bigwave:
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
Re: What is a Quality Engineer?

So basically if I had taken the time to take the training and test I would be the QE? I handle everything we do, including process returns and all regulatory issues, but our company is growing so fast I can't meet some of my personal deadlines.

You may be one already....you sound like you have the responsibilities. It is more a title game than anything. I have had Q techs or Q Mgr do the work QEs do in other firms.


Do you think the Dir of Ops just needs a statistician instead of a QE to get the data entered, trended and monitored?
Medic

If it was my decision, I would look for a QE (or to train a person to be QE) with strong statistical background. More flexibility.
 
M

medic61

Thanks Bob and Randy! I just needed to get the basic and the link Randy posted helped me a lot.
I knew I could depend on the Cove to point me in the right direction.
Medic
 
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