The head of a quality team is a quality manager.  This role consist of a person who makes all of the quality decisions.  In my field of work, industrial, those decisions entail releasing a product if it has an out of spec result, updating and monitoring SOPs, implementing new SOPs or MOCs of current SOPs, and assuring the lab is following said SOPs.  Those are just a few responsibilities of a quality manager.  This person also has multiple people reporting to him or her, and he/she is the main contact for the different departments. The qualifications of this positions is experience in management and with audits and its multiple types, GMP, GCP, etc.  I can see myself in a position like this because I currently work in the lab, so I know that part of quality fairly well, and if I was put in that position I would be able to implement different policies to make the business run better within my scope of the company.

Quality assurance and quality control are two sides of the same coin. The focus revolves around quality of the product, and for medical devices, this can be vital. Having a defect occur in a product can be costly, and may perhaps pose a risk to the patient. Therefore, I see both these fields as a crucial role to any medical device company and therefore, when asked if I would like to have a role in such a position the answer would be yes. Between the two however, I would probably choose quality assurance. 

Quality assurance, or QA, is focused on preventing any issues or defects to occur within the product, thus, having good quality assurance from the get-go is ideal. Focusing on the process of the product is also more interesting then investigating any issues and figuring out the root cause, in my opinion. This is more of something what quality control would do.

I personally can't see myself within a QA/QC role, no matter where that may be. QA and QC need to be able to take a fine tooth comb when reading through documentation and have a keen sense on when things may go against the quality manual or may fall out of compliance. They are also some of the people who must remain on their toes during their audit as they are the ones that need to show that we comply with our own SOPs and work instructions. From a QA engineer to the director level, I respect what talent they have to perform their role, but I personally have my own passion within the research and development side of medical devices. 

One of the roles in the quality management system is regulatory affairs specialist. The specialist help in obtaining and maintaining government approval for any medical device or drugs or any related materials. They work closely with the FDA since it’s the governmental department that  protects the public health and supervises medical devices, food, vaccines, drugs that are being manufactured and are in the market. Individuals in these positions have to work on document preparation, file maintenance, and coordination of tasks between multiple different departments in the company. Moreover, they have to ensure compliance with regulations, maintain data in the system, and identify relevant regulatory guidelines.

The requirements to enter such position is to have a Bachelor’s degree that’s related to the industry one is working in usually relating to biological sciences, chemistry, engineering or pharmacy. To advance in the position, one must obtain a Masters degree in the field. It can be relating to Business Administration, clinical studies, or even engineering. Just like any position, one can either further advance their knowledge by getting certified or credentialed; for example, Regulatory Affairs Certification.

The working conditions of that position is extremely demanding as one has to keep up with strict protocols and timelines. It can also be tedious when dealing with the government and lawyers because the processes are often very slow. Furthermore, one must be able to adapt quickly to changing regulations or working with new management tools.

I personally see myself in this position as I am someone who pays attention to detail, likes to work with different departments, likes to understand the whole product development process, and then deal with regulatory paperwork. 

A possible role in the field could be a Quality Assurance manager who is managing a team of engineers to ensure compliance to regulations and standards. A big responsibility would be to ensure that all procedures are adopted. For this role, a bachelors degree is mandatory and some type of additional certification would be desired. While this is an important and rewarding job, I do not think it is a fit for me. I prefer to work more hands-on when it comes to projects with CAD and other technical processes rather than reading through and preparing documents. If there was a role in quality assurance that was still very hands on every now and then, then I would somewhat consider it. However as of now, I am still not interested in quality assurance.

Is anyone familiar with any companies with QA roles that are still hands on every now and then or that are flexible and can involve other responsibilities as well?  

I can see myself working in the QA/QC process. I think the requirements for such a role should not be that stringent. Often times biomedical engineers will fill these roles but the job responsibilities involved can really be completed by most engineers or those that have studied relevant STEM fields. My ideal role would be in management where I can still be involved in the quality assurance process but still have a decision making role within my local organization. Additionally, a the cross-functionality of the position would be interesting by being able to understand and have a role in the operations of those in other departments.

The roles in the quality team vary between companies. Because I work in a very small company, the quality assurance and quality control team consist of the QA engineer/associate, a documents specialist, the QC associates and then the managers of both departments. From experience, the QA team seems to deal with the most documentation and paperwork. From the receipt of raw materials to the release of the final product, there are specific documents that must be filled out and must be done so in compliance with GDP standards. QA makes sure that all paperwork is done correctly and that all personnel has received all the proper training for their positions. QC, in my experience, spends their time in the lab conducting tests that make sure the product is within the guidelines set by QA. This includes sterility testing, bioburden testing, etc. If the product does not pass QC testing, then it cannot be released. Personally, although both departments require you to be meticulous and thorough, I would take a QC role over a QA role as QA deals with a lot of paperwork and not only for their own department but the paperwork for the other departments as well.

  I think working in the QA/QC industry is not suitable for me. The combination of so many detailed responsibilities makes me nervous. QA engineers are the people who examine a product in detail after it is produced and give approval or rejection to the product. I have a lot of respect for what QA engineers do, and I think it's a job that needs to be done very carefully. Especially in the field of medical devices, QA engineers need to be much more careful.

Thanks!

One of the few jobs that are fairly easy to attain is the position of a QC analyst, the person who performs QC functions and conducting testing on machinery that is laid out by the QA department. The qualifications of such job functions require the person to be minimally adept on the subject because the QA team sets up the testing and makes sure that the document, test document, is able to be reproducible many times and can be performed by different people with relatively small variations. This position i feel is a great starting position in regulatory and quality engineering as it gives a glimpse into what the language of the field is and what the quality life cycle is without being pushed into the deep end and having to write up these testing documents.

A career in quality management is a great career to be in.However some of the duties is they are are the final defense for a company.With this being said quality management has other QC and QA under them which are suppose to catch non compliance and correct it.The quality management reviews everything the QCs and QAs has in a sense they possible could have missed something or made a mistake.

One of the roles that I see in the space is a quality control manager. I could see myself in this role as there are a lot of pros to working in this position. Quality professionals have access to a wide range of critical positions and decision-makers in their industry who will elicit detailed answers from them. This will enable me to learn how a particular industry or organization functions. I would be exposed to the experiences and insights that would help me develop professionally through audits and assessments.

A quality control manager may assess any vendor items required for the production process and monitor the quality of the products for which they are accountable. To guarantee that the product's criteria are met and to develop quality standards based on those requirements, they would collaborate with other departments across the corporation. To ensure quality standards are always maintained, they could oversee more quality control inspectors or sporadically inspect workers' finished products.

Quality Control Manager Requirements:

• A bachelor's degree in science or business-based programs.
• Previous experience in production or manufacturing.
• Experience in business administration may be advantageous.
• Strong attention to detail, observation, organizational, and leadership skills.
• In-depth knowledge of quality control procedures and legal standards.

Since I have a bachelor's degree in business administration with a concentration in marketing and communication, I think I would pursue a role in the marketing department of Quality Assurance. I enjoy branding and understanding my target audience/ demographics. Developing a marketing strategy with visual elements to ensure the customers that our product is top quality and attempt to convince them that the device is the absolute need that they must have is fun. A lot goes into marketing such as budgeting, studying the analytics, collecting data, building a website, creating videos, perfecting product branding, and interacting with customers is the type of job I would like to get into if I consider wanting to work in Quality Assurance.    

There are several job titles that an employee can be given working under the quality management system (QMS) of a company. Some examples of these titles include quality engineer, quality assurance manager, director of quality, etc. Within these job titles, there are even more jobs specific to the tasks of an employee, such as quality assurance tester, auditor, or technician. Indeed provides a list of job titles with their descriptions for roles in quality control/assurance (linked below). Such job titles require employees to be detail-oriented and monitor all aspects of the manufacturing process to ensure the production of perfect products. Organized work environments and work methods (such as following procedures) is also extremely important for employees with these roles. I see myself succeeding in a position within the QMS of a company. I always pay close attention to detail and check (and recheck) my work. These characteristics are essential for roles in the QMS, especially quality control. In addition, I enjoy overseeing a process and making sure all steps were taken to successfully complete a task (or develop a product). Although both quality assurance and quality control roles are appealing to me, I see myself more within quality control because I’d be doing more hands-on testing and checking of devices instead of writing procedures and explanations for how products should function. 

10 Job Titles for Quality Assurance (With Salaries and Job Descriptions) | Indeed.com

Within drug development, QA is split into many departments. One department is called Floor Support QA and these workers are in charge of managing and reviewing batch records or written process instructions that are performed by the manufacturing associates/scientists as well as writing change controls and approving document changes. Production Support is another QA role and these employees are in charge of creating these batch records or written instructions while working with the clients to make sure that the instructions are in compliance with their process standards. Within the field I have chosen, I think I would lean more towards working in Production Support rather than Floor Support since I have more of a say in what the instructions would entail for the Manufacturing Associates/ Scientists and I would be able to get a clear idea of what the process would be comprised of so that I can make sure that the process would be in compliance with the FDA as well as the company standards. I would rather be in a more hands-on position especially because I would enjoy listening to the process and what the intended target is for the process. Since I also have experience within the scientist position, I think I would have a better understanding of what is allowed in the cleanrooms/ labs as well as how certain pieces of equipment function so that I could offer some insight to the clients as well. 

Then within QC, the two departments that I am knowledgeable about are QC Analytical and QC Environmental Monitoring. QC Analytical focuses more of performing data analysis testing for cells counts, viability and pH. QC Environmental Monitoring focuses more on how aseptic the Manufacturing Associates are while processing in the cleanroom and to make sure that there isn't any bacterial growth or particulates within the cleanrooms. Out of these two departments, I think I would rather go into QC Analytical since it is more lab experience and will offer more opportunities for learning all the different types of cell count equipment.