What does a quality specialist do?
Quality control senior scientists ensure that testing, materials, and laboratory equipment are up to standard. In the course of their career, they can expect to perform tests for the quality of manufacturing processes in order to ensure compliance with predetermined criteria, as well as ensuring that final products are safe for sale or distribution. This is a career that requires the skills of teamwork, communication, writing, and prioritization. Also, good attention to detail and some technical skills will be needed.
Quality specialist responsibilities
Here are examples of responsibilities from real quality specialist resumes:
- Manage CMOs that provide Endo with API, bulk, packaging services, and/or finish goods, including clinical material.
- Manage PPAP sample dimensional verification activities.
- Recommend changes to organizational committee structure to achieve higher level of accountability and oversight.
- Manage document control including initiating and revising procedures, QA approval and implementation of documents.
- Manage performance improvement and quality improvement projects design to assess and improve health outcomes for Medicaid members.
- Manage hospital core measures abstraction, registry abstractions and review services to assist healthcare organizations in improving performance.
- Ensure efficient process quality with the utilization of DMAIC.
- Maintain activities and documentation in compliance with quality requirements (GDP).
- Perform compliance review of control documents and execute audits of DMS document subsets.
- Communicate with facility leadership teams and SQF practitioner to ensure implementation of SQF standards.
- Provide support to internal and agency inspections including in person contact with regulatory agencies as SME.
- Create or revise procedures as necessary to maintain compliance with 21 CFR 210 , 211, and 820.
- Review of the equipment records and DMS information if applicable to approve out of service machines for use.
- Develop and implement quality relate EMR reports.
- Participate in customer/regulatory audit to perform GDP audit review.
Quality specialist skills and personality traits
We calculated that 8% of Quality Specialists are proficient in Customer Service, Data Analysis, and Continuous Improvement. They’re also known for soft skills such as Creativity, Listening skills, and Math skills.
We break down the percentage of Quality Specialists that have these skills listed on their resume here:
- Customer Service, 8%
Accredited quality of life specialist that cared for seniors within a facility setting, provided outstanding customer service guaranteeing life excellence.
- Data Analysis, 6%
Facilitated quality system management by ensuring product and process quality through internal audits, data collection, and data analysis.
- Continuous Improvement, 6%
Lead a team to develop Supplier Quality/Delivery performance dashboards for quality evaluation and instituted supplier quality workshops for continuous improvement.
- Process Improvement, 5%
Assist management in compliance and process improvement utilizing Six-Sigma, ISO and Continuous Process Improvement methodologies and consistent training and engagement.
- Management System, 5%
Partnered with suppliers to establish and initiate an effective corrective action and root cause analysis program within their quality management system.
- FDA, 5%
Reviewed and approved equipment calibrations, qualifications, and validations for adherence to company procedures and FDA guidelines.
Most quality specialists use their skills in "customer service," "data analysis," and "continuous improvement" to do their jobs. You can find more detail on essential quality specialist responsibilities here:
Creativity. One of the key soft skills for a quality specialist to have is creativity. You can see how this relates to what quality specialists do because "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." Additionally, a quality specialist resume shows how quality specialists use creativity: "manage sample inventory worth $500,000+.product quality specialist"
Listening skills. Another soft skill that's essential for fulfilling quality specialist 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 specialist resume, here's how quality specialists can utilize listening skills in their job responsibilities: "delegated to the call listening team where we ensured that calls were being graded appropriately to the standards set by cms. "
Math skills. Another skill that relates to the job responsibilities of quality specialists is math skills. This skill is critical to many everyday quality specialist 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 presentations on non-conforming statistics for managers monthly quality review meetings using access and microsoft word applications. "
Speaking skills. A big part of what quality specialists do relies on "speaking skills." You can see how essential it is to quality specialist 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 specialist tasks: "experience speaking to auditors from fda, ema, mexico, and turkey. "
Writing skills. Another crucial skill for a quality specialist to carry out their responsibilities is "writing skills." A big part of what quality specialists relies on this skill, since "industrial engineers must prepare documentation for other engineers or scientists, or for future reference." How this skill relates to quality specialist duties can be seen in an example from a quality specialist resume snippet: "report writing includes fda sample collection & results of quality analysis, microbiological, water & surimi testing. "
Problem-solving skills. Another skill commonly found on quality specialist job descriptions is "problem-solving skills." It can come up quite often in quality specialist 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 specialist responsibilities: "resolved regulatory and quality issues by collaborating with sales, logistics, operations and fda personnel. "
The three companies that hire the most quality specialists are:
- CSL Plasma176 quality specialists jobs
- TPI66 quality specialists jobs
- Regions Bank52 quality specialists jobs
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Compare different quality specialists
Quality specialist vs. Auditor/quality
A quality auditor is responsible for inspecting the company's services and products, ensuring its adherence to business requirements and internal regulations. Quality auditors analyze the efficiency of operational functions and production processes to maintain high-quality deliverables with the utmost consideration for the safety and security of the production staff. They run quality checks for the outputs, create findings reports, and strategize methodologies to enhance stability by utilizing standard testing parameters. A quality auditor must have excellent communication and organizational skills, as they may also recommend opportunities to generate more resources and increase revenues.
There are some key differences in the responsibilities of each position. For example, quality specialist responsibilities require skills like "data analysis," "center management," "osha," and "patients." Meanwhile a typical auditor/quality has skills in areas such as "audit results," "calipers," "quality procedures," and "appeals." This difference in skills reveals the differences in what each career does.
Auditors/quality really shine in the retail industry with an average salary of $40,479. Comparatively, quality specialists tend to make the most money in the government industry with an average salary of $64,103.The education levels that auditors/quality earn slightly differ from quality specialists. In particular, auditors/quality are 3.8% less likely to graduate with a Master's Degree than a quality specialist. Additionally, they're 0.1% less likely to earn a Doctoral Degree.Quality specialist vs. Specialist-small business
A small business specialist develops new business programs to meet changing customer demands. They are responsible for ensuring integrity and consistency in the domain of business. They analyze causes of a business issue, obtain business data, and make enquiries. They are responsible for making purchase agreements, confidentiality arrangements, and joint venture arrangement.
While some skills are similar in these professions, other skills aren't so similar. For example, resumes show us that quality specialist responsibilities requires skills like "data analysis," "continuous improvement," "process improvement," and "management system." But a specialist-small business might use other skills in their typical duties, such as, "customer relationships," "business development," "business portfolio," and "business administration."
In general, specialist-small businesses achieve similar levels of education than quality specialists. They're 2.2% less likely to obtain a Master's Degree while being 0.1% more likely to earn a Doctoral Degree.Quality specialist vs. Quality assurance auditor
Quality assurance (QA) analysts are responsible for testing company products and processes. Through testing, QA analysts ensure that the product or process is ready for production. They check whether the process meets company standards and guidelines, as well as any standards related to the industry they are in. QA analysts are in charge of determining the root cause of any problems that they may encounter. They also try to solve these as soon as possible. They also ensure that the company's products meet user expectations as well as the company's brand promise.
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a quality specialist is likely to be skilled in "customer service," "data analysis," "continuous improvement," and "center management," while a typical quality assurance auditor is skilled in "clinical trials," "quality assurance audits," "audit reports," and "glp."
Quality assurance auditors earn the highest salary when working in the pharmaceutical industry, where they receive an average salary of $87,841. Comparatively, quality specialists have the highest earning potential in the government industry, with an average salary of $64,103.When it comes to education, quality assurance auditors tend to earn similar degree levels compared to quality specialists. In fact, they're 1.2% less likely to earn a Master's Degree, and 0.6% less likely to graduate with a Doctoral Degree.Quality specialist vs. Quality engineer
A quality engineer's responsibilities include ensuring that the manufacturing processes are efficient and accurate, documenting findings that would raise concerns, conducting quality tests while observing parameters, and implementing changes as necessary to meet the highest quality standards. Quality engineers need to have excellent problem-solving and observation skills to detect any irregularities and possible malfunctions. They also must be able to communicate effectively with the clients for feedbacks and corrective adjustments, address complaints, and immediately resolve any inconsistencies made.
Even though a few skill sets overlap between quality specialists and quality engineers, there are some differences that are important to note. For one, a quality specialist might have more use for skills like "customer service," "center management," "osha," and "dexterity." Meanwhile, some responsibilities of quality engineers require skills like "process control," "statistical analysis," "pfmea," and "gd. "
In general, quality engineers earn the most working in the technology industry, with an average salary of $84,890. The highest-paying industry for a quality specialist is the government industry.In general, quality engineers hold similar degree levels compared to quality specialists. Quality engineers are 2.6% more likely to earn their Master's Degree and 0.0% less likely to graduate with a Doctoral Degree.Types of quality specialist
Updated January 8, 2025
