I don't have experience in QC, but I would think the success of a QC person is significantly effected by the quality of work done in QA. If the QA did an outstanding job determining the structure and evaluations necessary to ensure the success of a product, it should be fairly straightforward for a QC person. At that point their job would primarily be management, testing, and determining if a product is accepted or rejected. 

One important skill for a QC Engineer to have is investigative skills. The role of QC is not only identifying non-conforming products. Failures sometimes require a root cause analysis. A root cause analysis is a method of identifying the reasons for a failure to occur. Several tools can be used to conduct a root cause analysis: Pareto charts, "The 5 Whys", a fishbone diagram, a scatter diagram, and an FMEA (failure mode and effects analysis). Being able to investigate and identify the reasons for failures is crucial in preventing future failures, which is especially critical in medical devices.

Having a clean and organized workspace is definitely important for a QC team member, but strong communication skills are also required. The QC department must be in constant contact with other departments like QA, in order to ensure they are in compliance with regulatory FDA standards. Another desired skill is attention to detail and patience when it comes to evaluating the product. Often times, QC cannot take any shortcuts when it comes to checking to see if the outputs match the QA's requirements. With careful selection of a QC team that exhibit these traits, along with proper training, the QC dept. would work well with QA to ensure that the finished product is safe, effective, and bound to succeed on the market.

I do not work in quality assurance however I have experienced multiple audits from the quality department of my company. As explained in this week’s lecture, there are work instructions for every possible job duty in my company. Whether performing a complex repair or simply disposing of a damaged part, employees are expected to follow step by step work instructions for every job duty. During a recent audit, the auditor spent about 20 minutes observing me perform my job as a technician. He was making sure that whatever job I was performing, the associating work instruction was pulled up on my computer. Furthermore, he ensured that I was following the work instruction step by step. He asked me questions regarding my training, qualifications, and credentials. He was simply trying to detect a fault in my departments operation in order to help us correct the issue.   

I think some of the skills that a QC engineer must have are usually part of the important core of skills that all workers should have; attention to detail, investigational and research skills, organization and diligence, work well with different people, and ability to adapt to a work environment. These are the norm, however, I think that one of the more important skills a QC engineer should have is maintaining adherence to all of the laws imposed by the company's policy and also regulatory agencies like the FDA and ISO. There will be times where a new device is created and the engineer will have no idea about it so investigating the device and finding information on its production, purpose, end results, and which regulations are imposed on it, will be very important in actually evaluating the quality of the device. 

I have a related question about this too. This is a question that my friend faces with his job. He is a biomedical engineer who works as a quality control person in a medical firm. He has almost two years of experience by now, and he always says that he still gets confused about what to do because two supervisors of his have different opinions on a matter. To give an example on a device, his quality control manager says the device is not in an okay condition to resume its process and leave the quality control department. At the same time, his boss either does some stuff on its own to the device or says it is okay to be processed. So my question is that in this situation, what can be done? One of his supervisors is the main boss, while the other is the manager od the department, and I cannot see a way that will make both supervisors happy. Any experienced quality control personal please share your thoughts on this.

As a quality engineer the most crucial qualities have been organization and the ability to find information. Organization has come in very handy when running validations. There are many moving parts, many things to keep track off and document (if it's not documented it didn't happen), many samples to make/ship/test. If you are running multiple validations at once, all the more things to keep track off. This summer I ran 3 different validations in parallel and if it were not for organization, then it would have been a mess.  Additionally, you need to be able to find information, to ask questions, to read through documents and investigate. This has come in handy when making decisions on non-conformances and to determine the impact on the final product and risk to the patient. 

I haven't been fortunate enough to be a part of a QC team but I would imagine that organizational skills play a tremendously important role in the success of this team. There should be a couple areas that a QC team should target and should have organized files for each of the key areas. These areas are product safety, product efficacy, and product defects. These should be a documented portfolio on the safety measures that need to be taking when using a specific product. Following this, there should be research proving that the product is effective for the target audience the product will be sold to. Finally, there should be a record of all the mishaps and defects that have been observed in the product and this data should be recorded for future updates of the product. 

While I have not had any experience in quality control, I can imagine the job is probably very stressful. Based on all the information given in the lecture, I think that it is very important that someone who is accuracy oriented with effective communication be apart of quality control. It is extremely important to be able to analyze information and data and be able to clearly communicate the results to management and the team. Accuracy-oriented people are important in QC as they can provide direct oversight of the processes and be able to produce reports as needed as documentation is very important in quality. 

Has anyone ever switched from R&D, manufacturing, etc to a role in quality? If so what made you do it and do your prefer quality? 

I have not worked in a quality role; however, I agree that organizational skills and communication are very important to the job. QC is part of every step of getting the product to market, from raw materials to release testing, so those in the QC department have a very important role in the company. If the product fails to pass any of the testing required for release, the QC department along with the QA department must investigate the issue and find the cause as to why the product failed. This includes not only more testing but also a lot of paperwork. It would make the job a lot more difficult if the person hired for the role was not organized, meticulous, or lacked communication skills.

I also have not had experience working in industry. After reading some comments, particularly @pi29’s, I certainly can see how organizational skills relieve potential stress and prepare you in the long run. I would imagine that each team member would be responsible for creating their own notes that would be compiled at the end of a workday/week. The purpose of these are to allow for reference if need be. I found skills such as this to be similar in capstone. At the end of every week, our team would write a detailed summary with necessary dates, times, specifications, etc., so that we could reference them at a later date. I found this strategy to be extremely helpful. A larger scale can be applied to QC, I’m certain. I believe it’s all about finding a method that works for the team and sticking with it.

In the past have had the privilege of working as a QC or QE, what worked out really well for me was having investigative skills. In the sense that, you have to be willing to dig into the problem and have the knack to figure out what actually caused the problem. Additionally QC or QE are a very dependent on other teams such as QA. If the QA has done a great job identifying and setting up the structure for evaluations, it becomes pretty straight forward for the QC. 

I do not have experience in the industry but, I did my internship in the quality control department of a large electronics company. In this process, as much as I observed, I learned that the QC personnel has great responsibilities. The biggest of these responsibilities is to examine the product very carefully. To find the source of the problem in any technical problem and try to solve it. The person at the head of the QC department should know the product very well and should know the smallest details about the product. Must be able to understand and solve the problem with a product.

Thanks!

In my workspace, I have had to do a very small amount of QC and QA in the form of executing IOQ, PQ, and OQs for the validation of machinery. Being on the executing side of the side, the biggest factor that affects how well I did the job was how well the test document was written and how detailed it was. For example, to test out the equipment, I needed a specific set of directions to get the QA to team their desired outcome. One of the biggest factors that came across was clear and concise language so it is clear to me what to do and so I don't get anything lost in translation. On the QA team, there was an understanding that the SOP that was written and the proper testing had to be essentially idiot-proof and that whoever was reading the proper documentation can execute the proper lab procedures having very minimal background in the subject