Looking for a job as Quality Engineer

[Katana_Clarity]

I have experience in Medical Device Quality Systems and Regulations, I even have an ASQ CQE. But I don't have work experience performing process validations, or SPCs. Thats where I am getting stuck in Job Interviews. How can I convince employers that I am qualified and capable enough to learn these things, and how can I get hired as QE given these holes? Also what can I do to patch these holes of inexperience without actually working? Any homework or essential reads?

 

[John Predmore]

I wish you success. I had the opposite challenge, I had plenty of real world experience with process statistics but not in medical device. It was not until I had job experience with one med device manufacturer that other companies would give me a job interview. But enough about me, back to your question:

I am qualified and capable enough to learn these things,

I offer one explanation. The potential employee doesn't want to hire a personal capable of learning or qualified for doing, they want a new hire who can go immediately to work with a minimum of coaching. I suggest there are certification courses in SPC where you can actually develop and perform SPC. The alternative of a book or video training on SPC does not provide a certificate. I encourage you to take a course that includes analysis of a real world problem with a real world client, because working with people to create an ordered project from scratch is different from a textbook problem. Sometimes the university will connect students with short-term internships, even if you work with no pay. Your local chapter of ASQ or engineering society would be another resource to find a client who could accept your free assistance in return for a letter of recommendation. That hands-on experience is what, I suspect, the potential employer is asking for from you.

Certification in process validation is not as readily available, but taking my idea one step further, you might enroll in a black belt program (which is sometimes offered through a university or ASQ) and if that project includes process validation, that would be certification that you have experience. I did a black-belt project for a non-profit organization and they were happy for my help. And, when you are asked in an interview about your real-world experience, you will have convincing real-world stories to relate to the interviewer.

 

[Katana_Clarity]

I wish you success. I had the opposite challenge, I had plenty of real world experience with process statistics but not in medical device. It was not until I had job experience with one med device manufacturer that other companies would give me a job interview. But enough about me, back to your question:


I offer one explanation. The potential employee doesn't want to hire a personal capable of learning or qualified for doing, they want a new hire who can go immediately to work with a minimum of coaching. I suggest there are certification courses in SPC where you can actually develop and perform SPC. The alternative of a book or video training on SPC does not provide a certificate. I encourage you to take a course that includes analysis of a real world problem with a real world client, because working with people to create an ordered project from scratch is different from a textbook problem. Sometimes the university will connect students with short-term internships, even if you work with no pay. Your local chapter of ASQ or engineering society would be another resource to find a client who could accept your free assistance in return for a letter of recommendation. That hands-on experience is what, I suspect, the potential employer is asking for from you.

Certification in process validation is not as readily available, but taking my idea one step further, you might enroll in a black belt program (which is sometimes offered through a university or ASQ) and if that project includes process validation, that would be certification that you have experience. I did a black-belt project for a non-profit organization and they were happy for my help. And, when you are asked in an interview about your real-world experience, you will have convincing real-world stories to relate to the interviewer.

First of all, thanks a lot for replying back. Your advice makes a lot of sense. I will be looking up for these SPC certification courses, but if you have any specific in mind, feel free to let me know. I used to go to local ASQ chapter meetings but COVID has made it really difficult to get the same level of interaction. Black Belt program might be out of my grasp right now as I dont hold that much of work experience,but that sure is a great idea. Thanks again.

 

[SpinDr99]

I too understand your predicament. I have two words for you YouTube (or is that one?). You can learn SPC from several of the tutorials there. And, you can probably find tutorials there to learn process validation as well. I learned SPC in my second position in Quality, and learned process validation later on. I think you'll find (as I have) that once you're in a regulated industry such as medical device, and achieved several Lead Auditor certifications (I suggest 9001, 13485 and AS9100), you'll be able to move into aerospace and your earning potential will increase greatly. Aerospace is its own "animal" so you might want to research the other aspects of that industry (conflict minerals/reporting, RoHS and REACh regulations. Good luck!!