Day in the Life: Quality Engineering 2, Medical Devices

Quality Engineering at a large company building medical devices. Video details the bones of a CAPA (Corrective Action Preventative Action) project.

[@justinlastname9068]

Thank you for posting these videos. They give more perspective than what's taught in class. I really appreciate it.

[@jobtalk9793]

So glad to hear they are helping you! My hope was to provide more perspective of the type I felt was lacking during my college years. Feel free to give me questions or topics you'd like to see covered.

[@yeahmarn9369]

These videos show me how each position is working in which way.......Thank you for sharing these knowledges.

[@surajpanigrahi6540]

It would be helpful if you could cite an example of a CAPA project. It will be a great way to understand the job role better. Can you make one video where you cite a case study of a CAPA project?

[@jobtalk9793]

I haven't been focusing on making videos recently, but this would be a good one to add for sure. Thank you for the suggestion

[@himanshuaundhe1499]

So basically, the 8D method of problem solving?

[@joshuacharlery8529]

Exceptional Fam!

[@baljindersinghsidhu3959]

U r so amazing.. explained everything precisely what needs to be known.. makes my work easy literally..🙏🥰 Thank you. Be my mentor PLZ..😁😁

[@Samcanplaymusic]

This is something not particularly appealing about QE to me: I really like the jobs that are heavily involved on the shop floor (dealing with defect analysis, CpK, RCCA, etc.) but many quality jobs revolve around passing audits or other roles that essentially take you off of the shop floor. Maybe you like that aspect; I'm not sure, but personally it's a bit of a turn off to me when roles are mostly desk work/emails and meetings.

[@thatguy4010]

I really like the content which you have posted. Really informative!!! The way you narrate is also fantastic. Which software do you use to make the animation?

[@jobtalk9793]

Haha. Sorry I missed this comment a year ago. In case you are still wondering, I used FireAlpaca and recorded it with QuickTime Player.

[@vishnukaru4949]

Hope you are doing well.

[@callmelos9243]

Outta all the different types of engineering jobs you’ve had which one would u say u enjoyed the most? And why?

[@jobtalk9793]

I enjoyed the manufacturing engineering job the most because it constantly kept me on my toes and interacting with lots of different people. I'm a naturally high-energy person, so I naturally love having a larger amount of things going on at once. I also loved that every day was completely different.

[@callmelos9243]

JobTalk would you say you was paid enough compared to the amount of work you did as a manufacturing engineer

[@siiinsei1050]

Can I email you a resume? I've always enjoyed reading quality system textbooks, and getting extremely hooked into Juran and Ishikawa.

[@dereklee6596]

Do you have a FE or PE signing off on those documents?

[@tatianewuli9130]

It seems that QEs have less professional freedom than IEs and DEs since they need always ask for approval and wait for managers responses . Am I right?

[@jobtalk9793]

I think this depends on the role and the industry. Some QEs can have professional freedom in designing solutions to company problems and in setting up programs for quality. Other QEs do have to follow the books in reviews and making things audit-ready. In the design world, design engineers can sometimes have less freedom in their constraints from customer, managerial and quality requirements. Other design engineers have lots of freedom to simply explore ideas. This can also change within one given role as managers change.

[@hetpoptani3579]

What did you answer when asked, why did you switch from QE in automotive assemblies to QE in medical devices ?

[@jobtalk9793]

I moved to a new city. When I was applying for jobs in that city, I noticed there were more opportunities in medical device than in the heavy industry. It seemed like a good move to go into medical device so that I would have more opportunities available to me, should I need to switch jobs again.

[@hetpoptani3579]

JobTalk I would really appreciate if you could suggest me any answers for this question of changing the QE field from automotive to medical device or hollow metal door or electronics.

[@jobtalk9793]

@@hetpoptani3579 I'm confused by your question. If you are asking how you can make the switch, my recommendation is to tailor your resume for each specific job application you submit - ensure you call out parts of your past that the company could use. Then just keep sending applications until you get to where you want to be.

[@Samcanplaymusic]

@@jobtalk9793 I think he was asking how you justify an industry change; for instance, wanting to go from the electronics industry to aerospace, or from the automotive industry to medical devices.

[@jobtalk9793]

​@@Samcanplaymusic @HET_POPTANI I think if the experience fits well enough, you don't need to work very hard to justify an industry change - either on your application or in person. The issue is when your experience does not fit very well AND you are switching. That's when it would be worthwhile to put an explanation in a cover letter and be prepared for questions during interviews. Also ensure your goal in applying (or why you are switching industries) for the job is clear at the top of your resume if your experience does not speak for itself.

[@mohamadnizarkezzo1974]

Is there an email you can be reached at? My group is interested in what you're doing! You can find me on linkedin with the same name.

[@Eban047]

Thanks for the video! This was great to see what QEs can do in a day-today basis! I'm currently finishing up school and looking to apply to QE jobs as an entry level engineer. Do you have any tips for someone without QE experience but analyst/research/manufacturing experience to get into the field? Any help is appreciated, thanks!

[@jobtalk9793]

If you are coming fresh out of school and have manufacturing experience, my main advice would be to get your resume reviewed, practice interviewing and be prepared to interview well. It sounds like your degree and experience should cover the needs of any entry-level quality position.

[@luckyhands64]

I would advise you to take the American Society of Quality QE certification. It’s open book and will allow you to standout. Also familiarize your self with QE documentation (ppap) etc

[@ezhilvanan1866]

Hi

[@YouSoundButtHurt]

Are you still a QE? How's it going?

[@jobtalk9793]

I am still a QE. I am at yet a different company (still medical devices) - I got a job closer to home. This quality engineering position is slightly different as it revolves around complaint evaluation.

[@YouSoundButtHurt]

So FDA 21 CFR Part 820? Fun stuff... they're supposed to merge/be replaced with ISO 13485 but who knows when that will happen.

[@lydjoy3385]

this was so helpful, thank you so much!!