Quality Myths and Lessons Learned

January 18, 2023

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What words cause the most problems in MedTech, and what situations should you be ready to handle when you work in Quality? Today’s guest wrote about these issues in his book and will be talking more about them in today’s interview.

Kevin Becker has a bachelor’s degree in Mechanical Engineering from the University of Minnesota and a Master's degree in Reliability Engineering from the University of Maryland. Kevin is an ASQ Certified Quality Engineer, Reliability Engineer, and Six Sigma Black Belt with experience as a Quality/Reliability Engineer, Quality Manager, Director of Engineering, and Director of Quality in the medical device field. Kevin has authored and co-authored published papers in the areas of reliability, probabilistic risk assessment, and measurement correlation and has written a book titled Quality Myths and Lessons Learned.

Listen to the episode to hear what Kevin has to say about ethical considerations in Quality, Quality’s PR problem, and why having a principle-based decision-making process matters.

Listen now:

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Some of the highlights of this episode include:

  • What prompted Kevin to start a consulting business

  • Examples of things few engineers realize

  • How you grow the muscle of realizing what you’re incentivizing

  • What a quality engineer might specifically be interested in with regard to ethics

  • Gray areas in ethics

  • How to use flow charts

  • Having a principle-based decision-making process

  • How a competitive culture can lead to pushing the rules

  • Overcoming peer pressure in the industry

  • The most important part of a quality management system


Kevin Becker's LinkedIn

Quality Myths & Lessons Learned Book

Etienne Nichols LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Kevin Becker:

“Communication is another issue that is really difficult for engineers. They should be good at it, but they’re not.”

“The worst possible answer is wrong but believable.”

“I’ve seen some flow charts that have a lot of circular loops, and I don’t think they help make things clearer.”

“The goal of any company should be: recognize (ethical deterioration) long before it gets to an ethical or, even worse, legal consideration, and then take action to correct it in a timely fashion.

About the Global Medical Device Podcast:


The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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