Exploring Careers in Quality Management

“So what do you do for work?”

If you’re in the Quality Management field, you might not be looking forward to this question.

There are a couple of different approaches. You can mention that you work in “Quality” in the “enter specific field here”. There’s a good chance they will look at you kind of confused and not ask any follow-up questions because it sounds a bit boring (90% success rate, personally). 

Or you can try to actually explain what you do. Now, there are a lot of different careers in Quality Management, so this will have a higher or lower success rate depending on the specifics. But unless you have a couple of uninterrupted minutes (or you can convince them to read this article), the average person will still have no idea what you do on a day-to-day basis.

The point is that Quality Management is completely unknown to most people. Even within a company, most employees outside of Quality do not know what Quality does or just believe that management hired them to make things harder. 

If you’re ever hired to build a Quality department, the people hiring you will have some vague idea of what Quality means based on their past experiences, but trust me, you are on your own for all of the specifics. 

But, with all that said, you’ve found yourself here. Either you started at a company with a Quality department and you’re wondering how to make the switch, you’re in college and searching for what’s out there, or you are already in the industry and looking for positions to advance.

Welcome! Here at Hardcore QMS, we write about different subjects in the Quality Management field, specifically in the Medical Device industry. This article will break down many of the different careers in both the Quality Control and Quality Assurance sides of the industry to help you understand what career options are possible.

What industries have Quality Management Professionals?

For this article, I am focusing on Quality Management careers in manufacturing and related industries.

Many of these careers are in regulated fields, such as Aerospace, Automotive, Medical Devices, and Pharmaceuticals.  There are also Quality Management jobs in the general manufacturing and consumer goods industries, highlighted by the large number of ISO 9001 certificates.

What about software quality assurance?

This article will not cover any positions related to the nonregulated software industry. It is that industries’ fault that the career descriptions and job postings related to Quality are completely jumbled.  The software industry co-opted job names from a long-standing profession that dates back to the early 1900s, and I will not apologize for any disappointment or confusion.

What’s the difference between Quality Control and Quality Assurance?

Before I get started breaking down the different careers, let’s provide some background on the differences between Quality Control (QC) and Quality Assurance (QA).

QC is a set of activities performed once something is manufactured, including testing, inspecting, and analyzing defective materials. In my perspective, this ignores aspects of Quality Engineering, so I will broaden the definition to all hands-on activities related to manufacturing.

QA is considered a “proactive” approach to quality, building processes and systems that lead to a high-quality product or service.

Note: These terms will be used randomly in your career. You may be a “Quality Assurance Inspector” or a “Quality Control Auditor”. As I said, no one outside of Quality has any clue what Quality people do, so try to take everything I say related to specific terminology with a grain of salt.

Salary and “can be done remotely” Chart

Quality Control Careers

Quality Inspector

Quality Inspectors are the most hands-on professionals in the Quality field. They use a variety of measuring tools like calipers, height gages, micrometers, electronic instruments like coordinate measuring machines (CMMs), and others to measure and test products. Their job is to see if the parts and articles meet internal specifications and requirements and identify nonconforming materials.

Quality Inspection is the most “trade” like profession in the Quality space, specializing in one specific area that requires some level of physical labor. 

Quality Inspectors have to understand or learn basic math, geometric dimensioning and tolerances (GD&T), and measurement techniques.

Quality Inspection is often the entry-level position for people on the QC side of things, especially for people without a college degree. That being the case, many Quality Inspection jobs start at the lowest end of the Quality payscale, around $35,000-$60,000 a year.

Once you are in a Quality Inspector there are a few options available. You can transition to a higher level QC role like a Technician or Quality Engineer, or even branch into QA depending on your company (this is the route I took). Alternatively, you can take the experience gained in the manufacturing space to move into a different manufacturing area.

Outside of advancement, if you like your role in Quality Inspection, there is a very high upside for an exceptional Inspector. Please understand that these opportunities are rare, and you will have to specialize, obtain certifications in an industry involving welding or aerospace, and possibly relocate. 

But, at this high end, there are Quality Inspection positions available that pay over $100,000 a year without requiring a college degree. The other benefit at this level is that despite what people will say, you are less likely to have your position taken by AI than other Quality roles. If the materials could be inspected by computers, they probably would be already. Quality Inspection still exists because it is hard to automate the inspection of complex products produced at low volume.

Quality Technician

Quality Technicians share a lot of similarities with Quality Inspectors, as many companies treat it as a natural progression from the Quality Inspection role.

Quality Technicians still inspect and test products and write up nonconforming materials. All skills from Quality Inspection apply, however, there are added responsibilities and expectations. 

For example, a Quality Technician may begin training Quality Inspectors, investigating nonconformances, maintaining audit schedules, and collecting data related to product quality. If a Quality Inspector is the one running a CMM, a Quality Technician could be the one programming the CMM. 

Quality Technicians might also start performing activities related to QA, such as participating in internal audits, maintaining documents, and handling corrective actions.

Being a Quality Technician is another career that can be done without a college degree. From a review of job postings, the average requirements for a Quality Technician are a high school diploma and two to four years of experience (typically gained through Quality Inspection or time in a manufacturing environment). It could also be a job acquired through an associate’s degree or training in a manufacturing role like machining. 

Quality Engineer

Quality Engineering is incredibly broad, so it’s hard to pin down everything a Quality Engineer might do in this article. Quality Engineering can include manufacturing-focused positions, specialization in processes like validation, or QA-focused roles.

A manufacturing-focused Quality Engineer handles statistical analysis, performs complex root cause investigations on nonconforming materials, builds out inspection and control plans, validates processes, and plans process and product improvement efforts.

A QA-focused Quality Engineer may work on the Quality Management System (QMS), communication and investigations regarding customer complaints, audits, and improvement of non-manufacturing processes (speeding up product distribution).

There are also many different subgroups and specializations within Quality Engineering, especially at larger companies. Some Quality Engineers only work on equipment and process validation whenever a piece of equipment moves or a manufacturing process changes. Design Quality Engineers perform risk analysis and evaluate new products for manufacturing and quality impact.

Quality Engineers need to have a strong foundational knowledge of Quality principles and statistics. They should understand problem-solving techniques (8D, Ishikawa diagrams, Pareto charts), the Plan Do Check Act (PDCA) cycle, statistical control, and more. In my opinion, the heavy use of these tools makes Quality Engineering the most “true-to-Quality” career available. 

It’s also useful for Quality Engineers to understand Lean and Six Sigma principles. If you want to gain credentials in Six Sigma, you can learn more in my article about passing the Certified Six Sigma Green Belt exam. 

Quality Engineering is the point where we move from Quality “trades” into a professional career. That being the case, becoming a Quality Engineer typically requires a bachelor’s degree, specifically in engineering (mechanical, biomedical, manufacturing, etc). In fact, many mechanical and manufacturing engineers start their careers as Quality Engineers. 

However, there are some exceptions, and it is possible to advance to a Quality Engineering position with an associate’s degree or accumulated on-the-job Quality experience. (Note, this applies to US-based positions, as countries like Canada have protections in place dictating that you can only have “Engineer” in your title if you have an engineering degree).

Entry-level Quality Engineers sometimes earn less than their counterparts in other areas of engineering, however, the pay range for Quality Engineers is large, and there are lots of growth opportunities. On average, a Quality Engineer can expect to earn between $75,000 (at the very entry level) and $140,000 depending on education and experience. There are even positions for Senior Quality Engineers available that pay upwards of $175,000 a year.

Also, while many career certifications provide marginal utility at best, the Certified Quality Engineer (CQE) certificate offered by the American Society of Quality is beneficial and sought by employers. If you are new to Quality, this won’t help you get a job in Quality Engineering as it requires eight years of experience or four years of experience with a bachelor’s degree, but it is worth pursuing if you want to advance in Quality.

Supplier Quality Engineer

Supplier Quality Engineering is a subgroup of Quality Engineering that focuses on materials coming in the door. A Supplier Quality Engineer should have all of the same skills as Quality Engineers that were listed above, but their day-to-day responsibilities will focus on interactions with suppliers and supplied material.

For example, a Supplier Quality Engineer will manage incoming inspection efforts, monitor supplier metrics and nonconformances, and handle the administration of Supplier Related Corrective Actions (SCARs). They might also perform supplier audits or visit suppliers to help work through quality issues related to products.

Supplier Quality Engineering roles require more experience than entry-level Quality Engineer roles, and someone may have to work as an engineer or Quality Engineer for a few years before transitioning into Supplier Quality Engineering. The pay scale reflects this experience, and a Supplier Quality Engineer can expect to earn between $90,000 and $160,000 a year.

Quality Assurance Careers

Quality Assurance/Compliance/Systems Specialist

Now, we are venturing over into the QA side of things. For ease, I am lumping a bunch of different job titles into this one category, including:

• Quality Assurance Associate
• Quality Assurance Specialist
• Quality Compliance Specialist
• Quality Systems Specialist
• Quality Specialist

These jobs have very similar duties, and they are based on doing everything related to Quality Assurance and the QMS. Also, the industries with the highest number of these positions are the Medical Device and Pharmaceutical industries.

The specifics will vary greatly depending on the position and industry, but some of the activities included under these job titles include:

• Running the document management system.
• Administering the electronic Quality Management System (eQMS).
• Writing Standard Operating Procedures (SOPs), Work Instructions, and other Quality-related documents.
• Coordinating a company’s training program.
• Performing Internal and External audits.
• Leading Change Control Efforts.
• Tracking and trending quality data.
• Supporting customer, registrar/notified body, and regulatory audits.
• Root Cause investigations for internal and supplier nonconformities.
• Creating corrective action plans and ensuring CAPAs are carried out.
• Investigating customer complaints.
• Preparing Management Review material. 

At a larger company, the position may focus on only one or a handful of the listed activities. But at a medium or small company, you may be doing everything on that list!

To excel in the role, a QA Specialist (and related titles) needs to have a background in Quality principles, as well as an understanding of Quality Management Systems. If you are interested in learning more about Quality Management Systems, especially for Medical Devices, our website is a great place to start!

In addition to similar skills as Quality Engineers, these careers rely heavily on writing ability. The role involves a substantial amount of paperwork and the creation and editing of SOPs and other documents. 

Many times, especially at smaller companies, QA Specialists venture into regulatory work. We’ll discuss some specifics with Regulatory Specialists below, but learning or having an understanding of specific regulations, both as they apply to the QMS and other aspects of the regulatory landscape, can be very beneficial.

Becoming a QA Specialist typically requires a bachelor’s degree, however, the type of degree can be more varied. Engineering degrees are useful, but depending on the industry, a Biology, Chemistry, Quality Management, or even an unrelated degree can be sufficient. 

There are positions available that do not require a degree, however, they do require experience to make up for the degree. In my opinion, this is what makes these types of roles the hardest jobs to get in the Quality space. This may seem backward at first, but all of the other roles either don’t require a college degree at the entry level (Quality Inspector or Technician) or can be worked up to by building experience in different areas of Quality. 

But, if someone cannot break into the industry, they aren’t able to get started getting experience to move up through the other careers. 

If you are interested in this type of career and don’t have a degree, my advice is to either start on the QC side of things or try and get an entry-level position related to Document Control. There are some Document Control positions (administrator, coordinator, or specialist) that don’t require a degree and can provide some of the background and experience necessary to move into QA.

A large number of different titles have been included in this section, which leads to a large salary range. An entry-level person in QA can expect to earn between $50,000 and $70,0000, while a more experienced person or Senior Quality Systems Specialist can expect to earn $90,000-$130,000 a year.

Regulatory Specialist

I’m including Regulatory Specialists as a subset of the group I talked about above, however, there are plenty of disagreements about the relationships between Quality and Regulatory.

Regulatory Specialists will have in-depth and experienced knowledge about the specific regulatory requirements of their industry. Taking my industry (Medical Devices) as an example, Regulatory Specialists are tasked with preparing and submitting Medical Devices for clearance or approval to the FDA and other foreign regulatory bodies. They may help with the QMS as well, however, the submission process is typically what separates someone into a Regulatory position.

Becoming a Regulatory Specialist requires at least a bachelor’s degree and a healthy amount of experience in the industry. An advanced degree is also beneficial.

If you are working in a Medical Device or Pharmaceutical company and want to move into the regulatory space, you should try and learn as much as you can about the submittal process and how information is communicated with regulatory bodies.

Being specialized and having more experience, Regulatory Specialists can expect to earn between $100,000 and $165,000 a year. This is a great career path for someone who wants to move into consulting, as companies often rely on consultants for the preparation of submission documents.

Quality Auditor

Outside of being a Quality Inspector, a Quality Auditor may be the only position on this list where you can explain what you do to someone at a party. 

Put simply, Quality Auditors audit companies to Quality Management System and other standards. Some of these standards include ISO 9001, AS91000, ISO 13485, ISO 14001, and ISO 27001.  There are positions available for Auditors in a wide array of industries, including general manufacturing, Aerospace, Medical Devices, Pharmaceuticals, and more.

There are two different types of Quality Auditors I am going to discuss in this article. 

The first is a Quality Auditor who works for a company in one of the above industries. These positions share similarities with Supplier Quality Engineers, however, more time is dedicated to auditing suppliers. Alternatively, a Quality Auditor may be focused on performing Internal Audits at their company or visiting different sites and performing Internal Audits at a larger company.

The second is a Quality Auditor who works for an auditing and accreditation company. These types of Auditors are responsible for visiting different companies to see if they meet the relevant standards and can receive their ISO 9001, ISO 13485, or other certificates.

A Quality Auditor can expect to spend almost all their time (3 to 4 weeks a month) traveling to different sites. For this reason, many Quality Auditors are semi-retired professionals who have spent their life in QA. However, I believe this is also a great career for someone younger, with 2-4 years of experience out of college, who would like to travel for work and is not interested in sales.

Becoming a Quality Auditor typically requires a bachelor’s degree that’s relevant to the specific industry (for example, biomedical engineering or chemistry for Medical Devices) and 2-10 years of experience in the industry, or a substantial amount of experience as a QA professional who is performing audits are part of their duties. 

Quality Auditing also requires outside education and certification as a prerequisite for the position. This could start with the Certified Quality Auditor certification offered by ASQ, but audit training on the specific industry standard is also necessary.

As far as pay goes, a Quality Auditor can expect to earn between $85,000 and $150,000 a year based on experience.

Quality Management Positions

Quality Manager

Now that I’ve gone over some of the individual contributor careers in Quality, it’s time to break down the Quality Manager position. Just as each title can be used for many different types of jobs, a Quality Manager position adds up all of the variance and is as unique to the specific company as a job can be. 

A Quality Manager could manage a specific department for any of the roles we’ve listed. There are Quality Engineering Managers, QC Managers, QA Managers, Quality Auditor Managers, Regulatory Managers, and more. Or, a Quality Manager could lead both the QC and QA programs at a site or company.

In the most basic form, a Quality Manager directs different Quality professionals, interacts with management in different departments, and controls the budget for Quality programs and tools.

One thing that makes a Quality Manager unique from managers of other departments is that the Quality Manager may be officially responsible for the company’s Quality and QMS. This means that they will be in charge of any ISO certifications at the company and will be speaking with federal agencies that come to inspect the company.

In the Medical Device world, the official responsibility is mandated by the FDA as the “Management Representative” who is in charge of the company’s Management Review Meetings and will be held responsible if they allow unethical Quality practices to take place.

To become a Quality Manager, the main thing needed is experience, experience, experience. Typically, this means 5-10 years of experience in a Quality department (Quality Engineering or Quality Assurance) of the relevant industry. 

You also need supervisory experience. For first-time managers, the experience is often obtained through promotion in their company. However, if you are not able to be promoted at your company, look to gain experience by leading projects and quality improvement efforts. Once you have gained experience leading projects, you can seek out other companies that are hiring Quality Managers. 

The certifications mentioned in the above sections can also be useful in becoming a Quality Manager. This includes Quality Engineer, Quality Auditor, and Six Sigma certifications. 

The salary for a Quality Manager will vary depending on experience and industry. The average pay for a Quality Manager is about $100,000-$120,000, with entry-level managers earning as low as $70,000 and senior managers earning upwards of $160,000-$200,000 a year.

Director/VP of Quality

At the very top of the Quality hierarchy are the Director of Quality and Vice President of Quality positions. 

The existence of this type of role depends on the size and geographical distribution of the specific company. At certain organizations, the Quality Manager is the highest level of the Quality department, while at very large corporations, there may be multiple VPs of Quality.

Directors and VPs of Quality usually have multiple Quality Managers reporting to them, and oversight over multiple or all of the sites in an organization. They are removed from the day-to-day activities of Quality and are instead focused on guiding their reports, setting company-wide Quality processes and objectives, and leading large-scale Quality improvement efforts.

Like many Director and VP-level roles, a lot of the focus is on strategy. This can include a company’s regulatory strategy, strategic planning, and resource distribution. 

The Director/VP of Quality may spend a significant amount of time traveling to the different parts of an organization and be on call in case any of the facilities are inspected by regulatory bodies.

This level requires a substantial amount of education and experience. A bachelor’s degree is typically a necessity, while a master’s degree or even a PhD may be required depending on the industry. A person could also have a combination of a Bachelor of Science degree in Engineering and an MBA or other business degree.

As far as experience goes, companies look for someone with 10-20 years of experience in the industry and 5-10 years of experience as a Manager (for director-level roles) or Director (for VP-level roles).

Being the highest level careers in Quality, Director and VP of Quality roles pay a substantial amount. For Directors, this can be anywhere from $140,000 to $220,000, while for VPs, this can be $200,000 to over $300,000 at a large organization.

Wrapping Up

Quality Management can be a challenging and rewarding career, with many different paths available depending on your interests. Hopefully, you were able to learn something or gain some interest in a new role through this article.

If you would like to learn more about Quality and Quality Management Systems, be sure to explore the site and sign up for our newsletter. Also, if you are looking for any advice and want to reach out, you can do so at info@hardcoreqms.com.