I worked as a QA co-op and recently finished in the summer. My day to day task varied depending on if any issues came up with machines or parts. On an average day, I would work on document updates and quality standard reference (QSR) updates. I would also work on my assigned CAPA which usually takes up most of the day for a good amount of time. I also spend a good portion of my time in the MRB room working on deviation reports. If we get a new machine, I would work on the validations for it. I also worked a lot with the manufacturing team to do investigative work on recurring part issues. So a QA's task daily really varies.

I helped the QA department when I was a CO-OP with Panasonic innovation center, and it was mainly focused on QA testing and validation for enterprise kiosks. they were short-handed so I didn't really get involved in everything. I only supported it part of my time, So I used to understand how the system should work and come up with a validation plane and write the document for test cases and scenarios. After that, I reviewed it with one of the senior engineers and if he approved it. I help to execute this plan and run the test for each scenario and document the outcome if it passes or fails with my comments. in this part is usually we find most of the glitches in the system if any. Then for practice, they would ask as to propose any correct of action if we can to fix the found issue.

From what I have observed during my working experience in Medical Device companies as Production Engineer, Quality seems to operate under two main strands: Quality (Ops) and Quality (Compliance).

As Production Engineer- I have gained experience with working both sides. Quality Ops also has two main areas that divides QC-finished product testing/inspection/acceptance activities that would involve Production Engineers if anything fails. Second area is more of Quality Assurance where Quality Engineers get involved from developing new product/inspection methods/evaluation in process deviations and non-conforming product dispositions etc.

I also have experience with Compliance side of quality. Cross-functional teams work to complete and submit CAPA reports with guidance of quality as well as Validations (IQ/OQ/PQ), change control-complaints etc.

As an intern in Quality (specifically Post Market Surveillance) I worked on a lot of root cause investigations for complaints and filled the appropriate paperwork to determine how the instrument malfunctioned. This included reviewing manufacturing batch records, lot numbers to find associated complaints, risk severity indices, as well as conducting a physical inspection of the product if available. I also worked on a risk management project working on remediating a Risk File for a design to meet the EU MDR compliance gap. I also completing trend analyses to identify reoccurring trends that may need an associated CAPA to be opened to improve device reliability and supported any regulatory requests for complaints information.

I'm personally not in QA/QC, but I work heavily with QA on a lot of my projects and know them very well. There are many roles in QA and QC that revolve in resolving QMS issues, CAPA/NC(s), product development, and auditing to name a few. For someone in a product development QA role, my coworkers are usually on multiple calls in a day to resolve areas of the design controls teams are either stuck on or need aid in defining terms to remain in compliance with our quality manual. They also review multiple documents for approval as gatekeepers within the QMS and they share their input on the risks that are associated with an item in a project. There have been times I've went from meeting to meeting with one of my QA coworkers since we are both representatives from our respective roles within the same two or three teams. They definitely catch multiple inconsistencies teams have in their documentation and ensure that a project is able to run without missing a document when it comes time to advance to the next phase of a project. 

As a Quality Assurance Specialist, my job is pretty routine depending on the day.  I work for a biotech/pharma company that manufactures immunotherapy treatments 3 days a week in 12-hour shifts.  My day starts at 4 am & I am either reviewing data for final product disposition or receiving patient lots as soon as I get in the building.  Most of these receiving days, I am also troubleshooting manufacturing issues with my colleagues and management as we want save the patient lots from unnecessary termination.  Once manufacturing has finished their processing, it is my responsibility to review the batch record for accuracy and GMP compliance.  My day can also consist of raw material approval, batch record issuance and verification, internal audits, and training.  When necessary, I also review nonconformances.  Working in QA is very different than working in Quality Control.  I have spent most of my career in QC as a Scientist in a number of different industries.  While I loved working in the laboratory environment, I really do enjoy working in QA because we get to see every part of the drug manufacturing process.  It can be a challenge, but it's more rewarding.  

I currently work in Quality Control, and a typical work day is as follows. I come in the lab, check my emails and look at my scheduled testing. I put my lab coat, safety glasses, and gloves on then I proceed to retrieve my samples from sample control (where the samples are housed). I allow them to reach room temperature prior to testing. Depending on the test and what time of day it is, I will take out any reagents/kits that are needed, and turn on any instrumentation needed for testing. I prioritize my day by testing the longest assay first, then completing any shorter testing that has to be done. Currently, we maximize the test load since we don’t have enough analysts trained to ensure we complete testing of specific lots. Once my testing is completed, I print out any data, clean up my lab bench and complete my data sheet. After that I place the results into LIMS (laboratory information management system), I give my data packet to another analyst to review my work and approve the data in LIMS. Once that is complete the day is pretty much done.

Quality control of manufacturing a product is super important. I worked in various industries, from tires to cell phone accessories, and finished goods ready for market is the end goal. Quality control is a big part of ensuring products are ready for the market. My company has lost time and money in both Industrials because a product did not pass inspection. Inspection is when a quality technician tests or inspects the finished goods to guarantee the product was produced to the correct specifications. If not, that can be an indicator of a breakdown of processes. In my experience, I have witnessed delays in shipment and recalls because specifications were off. You cannot tell customers they will not get their product in time because it isn’t up to par, especially when contracts are involved.

This past summer I had an internship where part of my role was to help with quality control for a civil engineering firm. In the morning I would go into the office and the head engineer would tell me what job sites he wanted me to inspect for the day and what was the expected work to get done. After being told which sites I would be inspecting for the day I would grab the site plans so I knew that the construction was in compliance with the set plans. While at the construction site I watched the work being done, looked at my plans, and talked to the laborers and foreman to ensure everyone was on the same page. By the end of the day I would write a report on what was completed by the construction company on the day and return to the office to give that report to the head engineer. At the time I did not realize it, but after listening to Dr. Simon's lectures on QA and QC, my job was heavily driven by quality control. There were times when things went smoothly and times when things went the opposite of smooth. This leads to another discussion, when in a situation when the quality is in question how should someone in a QC role handle it?

My experience in quality assurance stems from working as a clinical engineer who provides imaging services across a healthcare system. My job focuses on taking a proactive approach to maintain high quality of care and workflow efficiency within affiliated hospitals and clinics. My primary responsibilities are to perform safety testing, preventative and corrective maintenance, as well as calibrations on radiology equipment such as ultrasounds according to the manufacturers standards and as required by JCAHO, DHHS, ACR, MQSA and other regulatory agencies. Additional responsibilities include creating records on these processes for each equipment in our inventory through standardized radiology systems as required by regulatory bodies.

I have worked as a risk management intern for a medical device company and have spoken with a lot of team members who have worked in risk management for years. I would say that their day-to-day tasks are highly dependent on the types of projects they're working on. Working in risk management for a medical device company is uniquely interesting since there are so many ways consumers of the product can find ways to use it outside of how it was meant to be used. Unprecedented challenges come up frequently and quality engineers need to use their experience and judgement to pursue the best path in any given problem. There is also a lot of involvement in potential process improvements. Quality assurance has a uniquely overarching perspective of the different roles that each team (regulatory, product development, etc.) has and how they play into each other. This gives quality engineers the ability to see which steps in processes are lacking and can be improved to increase efficiency. Quality engineers do have a lot of base business tasks. They are needed for approval on nearly every single change made to a product. Quality engineers have a wide variety of work and need to be extremely detail-oriented to be successful in the role.

I work as a Supplier Quality Engineer, where many different things come to my plate. I would say my main job is to work with nonconforming materials and disposition them according to what I think the best plan is. If a material fails a critical dimension, it is my job to reach out to the supplier directly, send them samples as well as additional proof of the component's failure, and determine with them what the next steps should be. Internally, I have to determine how critical the error is and decide whether or not further external action needs to be taken. I would say this is 50% of my job. The other couple percent involves creating inspection plans for materials that have updated revisions, so our quality control team knows what to look for when the material is received and also create specification outlines for whenever a supplier may be offering us a new part or something in their location/tooling changes.

Last summer I worked as an intern in Quality Compliance at a medical device company. Within that function, my role was centered on working on Corrective Actions and Preventive Actions (CAPAs). The work consisted of monitoring CAPAs from the Request through the initial investigation, root cause investigation, action planning, action implementation, all the way to effectiveness verification. These CAPAs typically would arise from a nonconformance or an audit. Quality requires a lot of documentation that may seem tedious at times but is very important. Through working on CAPAs, I was able to get exposed to many Six Sigma principles such as conducting root cause analyses, drawing fishbone diagrams, and utilizing the five whys. Additionally, working in quality allows you to work with other members across different cross-functional groups, allowing for exposure to other departments within the company. Since the CAPAs are almost related to groups outside of quality, a lot of a quality engineer's day-to-day may consist of plenty of meetings.