Case Study: Medical Manufacturing Quality Controller Inspector

I have some experiences of working in medical manufacturing almost five years, but I have moved to Microvention Terumo about a year ago as Medical Manufacturing Quality Controller Inspector (QC) which known as a final step to make sure that the device has a great condition and match with the specifications before it lands on doctors’ hands to operate on patients. I always get the same question from people that if I am working in hospital since I am working with medical industry. Actually not, I don’t working in hospital, as a manufacturing we have a special room to work in and it calls Cleanroom (CR) which requires all associates to dress up with sanitized gown, cover hair with hair net, cover shoes with shoes cover, wear beard cover for men,
Some people think it is an easy job since they see the task of the job is just sit down and look at the microscope, but they don’t know that we have follow the specifications which have designed by engineers. The device calls “Implant” and each implant model has different length, size, and shape. Some of them have different type of beneficial based on the patients’ size and conditions. Every type of implants has the instruction which we call “drawing”. Drawing is a file where it explains the exact measurements for us to know where we have to inspect on. If QC would not catch the problem on the device, it could harm patients when the doctors do the operation. The device has sold to everywhere in the world, which means that our job as QC is also important as the part of doctors who do perform the surgeries. QC’s job could save patients from Ischemic Stroke, or Carotid Artery
As QC, everyone can share the concern to Quality Engineers (QE) or technicians who in charge of the device to improve or fix the mistake it has and prevent it from reject more and more. The higher level about QC always encourage us to speak up on what to help on the device from over reject. One time, there were a lot of rejects over the same problem, I went up to one of the engineers and told him we could prevent that from happening again by make sure the operators who work on that specific step to careful on one of the section. After few weeks after he did the studies on it, and it was true that the problem was caused by what I have brought up to him. He has to update the documents and train all the operators on that section to be aware of the problem and show them how to prevent the reject to happen again from that small mistake they make. I was surprised by his appreciation words that he brought up to my manager after the training. He said “The problem got fix now, if Rotana did not brought her concern to me, I would not know what caused that much of reject”. He continued with laugh “You should give her some bonus by the end of the year”, and my manager replied with a smile that “That is how my QC works!” As QC, sometime we have to show doctors how the process goes when they visit the company and do their studies with our device. We are the main