What does a quality engineer do? A quality engineer makes sure products are built right the first time and stay that way. They design inspection and test methods, run the quality management system, lead root cause investigations when something fails, and keep the company compliant with standards such as ISO 9001, AS9100, IATF 16949 or FDA rules for medical devices.
It is a role for people who like data, process and a bit of detective work. Quality engineers sit between production, design, suppliers and customers, so they spend as much time influencing people as they do analyzing numbers.
Key takeaways
- Quality engineers build and maintain the quality management system (QMS), prevent defects and lead corrective action.
- The standard depends on the industry: ISO 9001 broadly, AS9100 for aerospace, IATF 16949 for automotive and FDA 21 CFR Part 820 for medical devices.
- Core tools include FMEA, SPC, 8D, 5 Whys, fishbone diagrams, capability studies and measurement system analysis.
- O*NET lists quality engineer as a reported title for industrial engineers, whose May 2025 median wage was $102,440 per BLS.
- ASQ’s Certified Quality Engineer (CQE) requires eight years of relevant experience, with degree waivers for part of it.
What does a quality engineer do on a typical day?
No two days look exactly alike, but most revolve around preventing problems, catching the ones that slip through, and proving to auditors and customers that the process is under control.
| Duty | What it involves |
|---|---|
| Quality planning | Writing control plans, inspection plans and acceptance criteria for new products |
| Nonconformance handling | Reviewing rejected parts, deciding on rework, scrap or use as is, and documenting the decision |
| Corrective and preventive action (CAPA) | Leading root cause investigations and verifying fixes actually work |
| Process monitoring | Running SPC charts and capability studies to keep processes stable |
| Supplier quality | Auditing suppliers, approving first articles and chasing supplier corrective actions |
| Audits and compliance | Hosting customer, registrar or FDA audits and running internal audits |
| Customer complaints | Investigating field failures and returns, then responding to customers |
In a plant, a quality engineer might start the morning at a material review board meeting, spend midday on the floor with an operator investigating a defect, and end the day updating an FMEA or writing an audit response.
What is a quality management system and which standards matter?
A quality management system is the set of documented processes a company uses to control quality, from design and purchasing to production, inspection and customer feedback. Quality engineers help write, maintain and improve it.
ISO 9001
ISO 9001 is the general quality management standard used across industries. According to ISO, the 2015 edition was used by more than one million organizations worldwide and has now been replaced by ISO 9001:2026, so many companies are working through the transition with their certification bodies.
AS9100 for aerospace
AS9100, published through the International Aerospace Quality Group as the 9100 standard, sets quality management system requirements for aviation, space and defense organizations.
IATF 16949 for automotive
IATF 16949 is the quality management standard for the automotive supply chain. Automotive quality engineers also commonly work with OEM customer specific requirements and tools such as APQP, PPAP, FMEA, SPC and MSA.
FDA 21 CFR Part 820 for medical devices
Medical device quality engineers work under FDA rules. According to the FDA, the Quality Management System Regulation (QMSR) became effective on February 2, 2026, amending 21 CFR Part 820 and incorporating ISO 13485:2016 by reference. The FDA notes the update now specifically requires risk management.
What root cause and quality tools do quality engineers use?
Quality engineers are expected to know a standard toolkit and choose the right tool for the problem.
| Tool | What it is used for |
|---|---|
| 8D | A structured eight discipline problem solving process for serious or customer facing issues |
| FMEA | Failure mode and effects analysis to rank risks in a design or process before they cause failures |
| SPC | Statistical process control charts that show when a process drifts out of control |
| 5 Whys and fishbone | Simple methods to dig past symptoms to the true root cause |
| Capability studies (Cp, Cpk) | Measuring whether a process can reliably meet its tolerances |
| MSA and gauge R&R | Checking that measurement systems are accurate and repeatable |
| Design of experiments | Testing several variables at once to find what really drives quality |
Software matters too. Minitab or JMP for statistics, an eQMS for document control and CAPA, and ERP systems for tracking nonconforming material all show up regularly in job descriptions.
Recruiter tip: On your resume, quantify at least one root cause win: the defect, the tool you used and the result, such as scrap reduced or a customer complaint closed. Hiring managers for quality roles want proof you can close the loop, not just run the meeting.
Which industries hire quality engineers?
Any company that makes regulated or high consequence products needs quality engineers. The biggest employers we work with include:
- Medical devices and pharmaceuticals, where FDA compliance drives the role
- Aerospace and defense, built around AS9100 and strict traceability
- Automotive and heavy equipment suppliers working to IATF 16949
- Electronics and semiconductor manufacturing
- Industrial equipment, plastics, metals and consumer products
Medical device roles often pay a premium because of the regulatory load. If that side of the industry interests you, our post on whether biomedical engineering is a good career covers the broader field.
How much do quality engineers make?
BLS does not publish a separate occupation for quality engineers. O*NET lists quality engineer among the reported job titles for industrial engineers, so industrial engineer data is the closest official benchmark.
According to the BLS handbook, industrial engineers earned a median of $102,440 in May 2025. The lowest 10 percent earned less than $74,370 and the highest 10 percent earned more than $159,860. BLS projects employment in the occupation to grow 12 percent from 2025 to 2035, much faster than average.
Actual quality engineering pay varies with industry, regulation and certification. In our experience, medical device, aerospace and semiconductor roles tend to sit toward the top of the range, especially for engineers who have led FDA or registrar audits.
What education and certifications do quality engineers need?
Most quality engineers hold a bachelor’s degree in industrial, mechanical, manufacturing, electrical or biomedical engineering. Some move up from quality technician or inspector roles with an associate degree and strong experience.
ASQ Certified Quality Engineer (CQE)
The best known credential is the ASQ CQE. ASQ requires eight years of on the job experience in areas of the CQE Body of Knowledge, with at least three years in a decision making position. A college or technical degree waives part of that experience requirement.
The computer based exam has 175 multiple choice questions, 160 of them scored, with 5 hours and 18 minutes of exam time. It is open book. ASQ lists the exam fee at $550, and ASQ members save $100 on the initial exam fee.
Other useful credentials
Six Sigma belts, lead auditor training for ISO 9001, AS9100 or ISO 13485, and ASQ certifications such as Certified Quality Auditor or Certified Reliability Engineer are also common in job postings.
What is the career path for a quality engineer?
| Level | Typical focus |
|---|---|
| Quality technician or inspector | Measurements, inspection, data collection and basic documentation |
| Quality engineer I | Nonconformances, CAPAs, control plans and support for one product line |
| Quality engineer II or senior | Leading audits, supplier quality, FMEAs and complex root cause work |
| Lead or principal quality engineer | QMS ownership, regulatory strategy, mentoring and design quality |
| Quality manager or director | Running the quality function, compliance and customer quality performance |
Quality engineers also branch into supplier quality, design assurance, reliability, regulatory affairs or operations leadership.
How is a quality engineer different from a manufacturing engineer?
| Area | Quality engineer | Manufacturing engineer |
|---|---|---|
| Main goal | Prevent and detect defects; prove compliance | Build products efficiently and at the right cost |
| Key outputs | Control plans, CAPAs, audits, FMEAs, inspection methods | Process designs, work instructions, layouts, tooling |
| Measured by | Defect rates, complaints, audit findings | Throughput, cycle time, cost, uptime |
| Works most with | Suppliers, customers, auditors, regulators | Production, maintenance, design engineering |
The two roles work side by side and many engineers move between them. If you are weighing both, our guide to the skills manufacturing engineers need shows where the overlap is.
Recruiter tip: If you are applying for medical device quality roles, name the regulations and standards you have actually worked under, such as 21 CFR Part 820, ISO 13485 and ISO 14971, and say which audits you supported. Generic “compliance experience” rarely gets past a hiring manager in that space.
Frequently asked questions
Is quality engineering a good career?
For detail oriented engineers who like problem solving, yes. It connects to every part of the business, it is needed in every regulated industry, and the closest BLS benchmark, industrial engineers, is projected to grow much faster than average from 2025 to 2035.
Is quality engineering stressful?
It can be around audits, recalls or major customer complaints, because quality often has to say no to shipping product. Engineers who communicate clearly and back decisions with data handle that pressure best.
Do you need the CQE to get a quality engineering job?
No. Many quality engineers are hired without it, and ASQ’s experience requirement means most people earn it several years into their careers. It helps most when you are moving into senior or regulated roles.
What is the difference between quality assurance and quality control?
Quality control finds defects through inspection and testing. Quality assurance builds the systems and processes that prevent defects in the first place, and quality engineers usually work on both.
Can a mechanical engineer become a quality engineer?
Yes, and it is a common move. Mechanical engineers already understand drawings, tolerances and materials; adding SPC, FMEA and audit experience makes the switch easier. Our engineering resume examples show how to frame that experience.
Ready for your next quality role? Our medical device engineering recruiters place quality engineers in FDA regulated companies, and our manufacturing engineering recruitment team covers aerospace, automotive and industrial manufacturers. Send us your resume and we will match you with teams that value strong quality leadership.
