2 Replies


Posted by Aniket Chaudhari on Jul 6, 2019 6:48 am

Hello All,

Greeting of the day...!!!

I am Aniket Chaudhari from India. I am working in Medical device company as process engineer. I have experience in preparing quality system procedure as per ISO 13485 and 21 CFR 820, apart from that I have experience of preparing DHF file and process validation documents. However, as I have been working in this area since 2017. I would like enrich my knowledge in the six sigma tools like DOE, Test Method Validation (Gauge R&R), Process Capability etc.. and hence I would like to connect with the people who can enrich my knowledge in the six sigma tools.

Re: Introduction

Posted by Trish Borzon on Jul 8, 2019 8:48 am

Hi Aniket - welcome to myASQ!  Be sure to connect with members of the Six Sigma Forum at .

Also check out the learn about quality area - you'll find some basic information on DOE & Gage R&R. 

Thanks for being an ASQ Member! 

Re: Introduction

Posted by Keith Harasyn on Jul 10, 2019 12:38 pm

Hi Aniket,
Mine is a similar career path, although I have been part of the medical device field for a bit longer, being in this industry for the past 20 years.  SIx sigma tools are valuate to control variation (especially in parts from your suppliers) and improve incoming quality.  ASQ offers 3 levels of certification in Six Sigma based on your experience level: Yellow Belt, Green Belt and Black Belt.  (I have a CSSGB).  This will give you a basic understanding and knowledge of tools that you can apply to control processes.
In terms of the medical device field, there have been significant regulatory changes in the past 2-years (EU-MDR, harmonization through MDSAP, and ISO 13485:2016 to name a few).  I would be happy to connect with you to share my knowledge and understanding.  Good luck with your career path.