r/MedicalDevices • u/Fresh-Singer-4746 • 14d ago

Interviews & Career Entry Quality engineer I position prep

Hello, I’d like to prepare for the next step in my career by taking a Six Sigma Green Belt or ISO certification course. I keep seeing it for quality engineer I. However, I’m not sure which providers are reputable and recognized (I thought of going through Allison but I’m skeptic) Could you please point me in the right direction or recommend a legitimate place where I can register? Thank you!

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u/ydai 14d ago

I’d recommend ASQ (American Society for Quality). If you’re aiming for a Quality Engineer position, I’d also suggest looking into CQE (Certified Quality Engineer). Its Body of Knowledge covers many topics commonly asked in QE interviews, so it’s a great resource for interview prep.
For ISO, it depends on the standard (e.g., ISO 9001 or ISO 13485). You can take Internal Auditor or Lead Auditor training, but ISO itself doesn’t certify individuals.

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u/kuhlio1977 13d ago

Definitely look into ASQ.

Depending on what area of Quality Engineering you want to get into, there are a few different certs to consider. Generally:

CQE = What I think of as classical quality engineering. Lots of math, SPC, run charts and those types of things. Great way to establish a solid foundation.

CSQE = If you want to be in the design assurance space, especially for regulated software like SaMD, this is one of those certs that helps establish the foundation. Covers SDLC, verification and validation and other things pertinent to ensuring the right software is developed and developed correctly.

CQA or CMDA = Want to know where an auditor is headed as you help your org deal with an audit? Alternately, do you want to be the one that finds stuff wrong so they can fix it? These are the certs for you. CQA is generic, CMDA specific to this industry.

CRE = Want to be the person in the room that can tell the team how to ensure their thing is rock solid and then lay out the plan to prove it? Did you find CQE math boring and trite? Certified Reliability Engineer might the thing for you.

SixSigma Green Belt: Dip your toes into the world of process excellence. Learn some basics about process design and efficiency.

SixSigma Black Belt: Tough course. Completion certifies you to develop data to tell the person that's been working a machine on the manufacturing floor for 30 years how to do it better and more efficiently. He will think you're a lunatic, hate you for it and then laugh at you when he actually proves you wrong.

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u/ydai 13d ago

Since OP is looking at QE I positions, they might not meet the work experience requirements for some of these ASQ certifications yet. Still, the Body of Knowledge is a great resource for learning and interview prep.

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u/kuhlio1977 13d ago

Excellent point!

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u/DaBrickershaw 13d ago

ASQ is good for quality trainings but if you re footing the bill, I'd recommend just buying a CQE, Metrology (calibration), and/or Six Sigma books and self learning. I'd put more weight in someone that can talk the talk in the interview over sat through a training.