What does a quality systems engineer do?
In manufacturing facilities, a quality systems engineer is in charge of conducting regular quality inspections to ensure that products and procedures adhere to company standards and government regulations. Their responsibilities include gathering and analyzing data, performing extensive research, developing and implementing quality assurance tests, reviewing documentation and specifications, identify the strengths and weaknesses of existing systems, and creating solutions against problem areas. Moreover, a quality systems engineer typically leads teams to reach goals while implementing and promoting the company's policies and regulations.
Quality systems engineer responsibilities
Here are examples of responsibilities from real quality systems engineer resumes:
- Manage CAPA systems integration of recent acquisitions.
- Lead and drive product/process design responsibilities in a highly-regulate medical environment, including statistical validation per FDA requirements.
- Participate in FDA and annual ISO investigations, and follow-up activities including implementation and evaluation of effectiveness.
- Develop quality control plans and FMEA for all processes.
- Prepare facilities for AS9100 registration audits through QMS pre-audits.
- Update FMEA files according to failure mode occurrence and severity.
- Lead quality system improvements and modifications to improve efficiency and compliance to AS9100, FAA, and NADCAP requirements.
- Analyze and investigate root cause analysis on all non-conforming products and report, and plan and execute CAPA process as required.
- Implement continuous quality improvement initiatives through Kaizen events.
- Supervise all calibration activities to ensure that all monitoring and measuring devices meet QMS requirements.
- Generate electronic SPC charts as quality improvement effort to move from a paper to electronic environment.
- Perform non-conforming material analysis and disposition; perform MRB materials disposition and identifying corrective action to prevent future discrepancies.
- Collect and analyze appropriate data to demonstrate the conformity, suitability, and effectiveness of the QMS and evaluate continual improvement.
- Perform manual setups and operate all conventional and CNC tool room equipment.
- Train for parts set-ups for CNC machines-tools MORI-SEIKI, HAAS, and conventional lathes.
Quality systems engineer skills and personality traits
We calculated that 6% of Quality Systems Engineers are proficient in Continuous Improvement, Medical Devices, and CAPA. They’re also known for soft skills such as Creativity, Listening skills, and Math skills.
We break down the percentage of Quality Systems Engineers that have these skills listed on their resume here:
- Continuous Improvement, 6%
Fostered continuous improvement by application of Lean principles, such as performing process improvements and waste reduction for nonconforming processes.
- Medical Devices, 6%
Experienced with implanted metal medical devices.
- CAPA, 5%
Conducted DEFOA investigations and related Supplier CAPA administration on contracted/purchased commodity defects.
- Corrective Action, 5%
Participated in quality improvement projects, performed supplier certification audits and ensured suppliers incorporated corrective actions to remedy quality issues.
- FDA, 5%
Serve as Lead Auditor for on-site Supplier Audits (FDA and ISO), development and analysis of supplier assessment forms.
- Quality Management System, 5%
Provide leadership for the development and maintenance of the Quality Management System ensuring compliance to domestic and international regulations.
"continuous improvement," "medical devices," and "capa" are among the most common skills that quality systems engineers use at work. You can find even more quality systems engineer responsibilities below, including:
Creativity. To carry out their duties, the most important skill for a quality systems engineer to have is creativity. Their role and responsibilities require that "industrial engineers use creativity and ingenuity to design new production processes in many kinds of settings in order to reduce the use of material resources, time, or labor while accomplishing the same goal." Quality systems engineers often use creativity in their day-to-day job, as shown by this real resume: "maintained a database of documentation relating to product and materials including routing sheets, spc, and inventory control. "
Listening skills. Another soft skill that's essential for fulfilling quality systems engineer duties is listening skills. The role rewards competence in this skill because "these engineers often operate in teams, but they also must solicit feedback from customers, vendors, and production staff." According to a quality systems engineer resume, here's how quality systems engineers can utilize listening skills in their job responsibilities: "communicated with suppliers directly on corrective action/preventive action requests. "
Math skills. Another skill that relates to the job responsibilities of quality systems engineers is math skills. This skill is critical to many everyday quality systems engineer duties, as "industrial engineers use the principles of calculus, trigonometry, and other advanced topics in mathematics for analysis, design, and troubleshooting in their work." This example from a resume shows how this skill is used: "created management review statistics used to measure effectiveness and timeliness of the existing quality management system (qms). "
Speaking skills. A big part of what quality systems engineers do relies on "speaking skills." You can see how essential it is to quality systems engineer responsibilities because "industrial engineers sometimes have to explain their instructions to production staff or technicians before they can make written instructions available." Here's an example of how this skill is used from a resume that represents typical quality systems engineer tasks: "attended, addressed, and responded to internal and external audits relevant to tuv, iso and fda regulatory requirements. "
Writing skills. A commonly-found skill in quality systems engineer job descriptions, "writing skills" is essential to what quality systems engineers do. Quality systems engineer responsibilities rely on this skill because "industrial engineers must prepare documentation for other engineers or scientists, or for future reference." You can also see how quality systems engineer duties rely on writing skills in this resume example: "coordinate and maintain the ts 16949 quality system including calibration, corrective actions, and writing operating procedures and work instructions. "
Problem-solving skills. Another skill commonly found on quality systems engineer job descriptions is "problem-solving skills." It can come up quite often in quality systems engineer duties, since "in designing facilities for manufacturing and processes for providing services, these engineers deal with several issues at once, from workers’ safety to quality assurance." Here's an example from a resume of how this skill fits into day-to-day quality systems engineer responsibilities: "resolved complex and sensitive customer complaints with the highest quality customer service. "
The three companies that hire the most quality systems engineers are:
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Compare different quality systems engineers
Quality systems engineer vs. Quality assurance specialist
A quality assurance specialist is an individual who is responsible for monitoring, inspecting, and proposing measures to correct and improve a company's product. Quality assurance specialists need to outline quality assurance policies and procedures, making sure that quality standards are assured. It is important that a quality assurance specialist should have strong attention to detail and is excellent in data collection. This work may require a minimum of bachelor's degree and certification to get certified.
While similarities exist, there are also some differences between quality systems engineers and quality assurance specialist. For instance, quality systems engineer responsibilities require skills such as "medical devices," "quality management system," "qa," and "supplier quality." Whereas a quality assurance specialist is skilled in "patients," "cfr," "iso," and "management system." This is part of what separates the two careers.
Quality assurance specialists earn the highest salaries when working in the pharmaceutical industry, with an average yearly salary of $76,157. On the other hand, quality systems engineers are paid more in the technology industry with an average salary of $89,087.On average, quality assurance specialists reach similar levels of education than quality systems engineers. Quality assurance specialists are 5.0% less likely to earn a Master's Degree and 0.4% more likely to graduate with a Doctoral Degree.Quality systems engineer vs. Quality lead
A quality assurance (QA) lead is responsible for organizing and managing the testing of products prior to its release. Your duties will include defining testing standards and strategies, establishing formal QA processes, and overseeing all aspects of QA, such as using best practices and establishing metrics. Additionally, you are responsible for supervising and mentoring QA team members, and developing and implementing scripts, test cases, and procedures. You are also responsible for managing off quality products and developing and institutionalizing ISO complaints.
In addition to the difference in salary, there are some other key differences worth noting. For example, quality systems engineer responsibilities are more likely to require skills like "medical devices," "quality management system," "qa," and "risk management." Meanwhile, a quality lead has duties that require skills in areas such as "project management," "management system," "customer service," and "iso." These differences highlight just how different the day-to-day in each role looks.
On average, quality leads earn a higher salary than quality systems engineers. Some industries support higher salaries in each profession. Interestingly enough, quality leads earn the most pay in the health care industry with an average salary of $92,715. Whereas quality systems engineers have higher pay in the technology industry, with an average salary of $89,087.Average education levels between the two professions vary. Quality leads tend to reach similar levels of education than quality systems engineers. In fact, they're 2.8% less likely to graduate with a Master's Degree and 0.4% more likely to earn a Doctoral Degree.What technology do you think will become more important and prevalent for quality systems engineers in the next 3-5 years?
Theodore T. Allen Ph.D.
Associate Professor, The Ohio State University
Quality systems engineer vs. Engineer
Engineers are highly trained professionals who determine the feasibility of various projects, usually related to the construction industry. They are considered experts in mathematics and science, two disciplines that they need to use in designing and coming up with plans for projects. They should also be well-versed in different construction or industrial materials, and they ensure that appropriate materials are used for the project. They also ensure that the projects meet the requirements of the groups that hired them. They create spaces that would both address the needs of the end-users and the industry standards. They also ensure that the projects they make would stand the test of time.
The required skills of the two careers differ considerably. For example, quality systems engineers are more likely to have skills like "continuous improvement," "medical devices," "capa," and "corrective action." But a engineer is more likely to have skills like "python," "cloud," "c++," and "c #."
Engineers earn the highest salary when working in the automotive industry, where they receive an average salary of $97,672. Comparatively, quality systems engineers have the highest earning potential in the technology industry, with an average salary of $89,087.When it comes to education, engineers tend to earn similar degree levels compared to quality systems engineers. In fact, they're 2.7% less likely to earn a Master's Degree, and 0.9% less likely to graduate with a Doctoral Degree.Quality systems engineer vs. Quality coordinator
A quality coordinator is responsible for monitoring quality control and testing procedures, ensuring that the processes and policies adhere to the company's standards and business requirements. Quality coordinators assist the project management team in developing strategic techniques according to clients' specifications from conceptualization to the final outputs. They recommend cost-reduction materials depending on the budget limitations, as well as conducting audits and creating reports. A quality coordinator must be highly organizational and communicative, especially on suggesting opportunities to increase revenues and drive more client partnerships.
Types of quality systems engineer
Updated January 8, 2025
