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What is a Quality Engineer?

  • An Image to suggest the role of a quality engineer

A Quality Engineer works within the quality team to ensure the overall quality of a manufactured product and is tasked with creating documentation, devising quality tests and defining the criteria a test result should meet. They play a key role in fixing issues when they arise.

Some companies might call this role: QA Engineer, QC Engineer

Let’s take a closer look at the details of quality and the role of a quality engineer.

What is Quality Engineering?

A quality engineer works within a wider team of quality professionals with the overall aim of maintaining the quality of the final product. They do so by following the quality management systems of the manufacturing process.

Successful quality engineering ensures that final products are safe and meet customer expectations while keeping the manufacturing process as effective and cost-efficient as possible.

Quality engineers work with various stakeholders, at every part of the manufacturing process. Examples include working with:

  • Design teams – testing to identify product durability and areas of weakness
  • Suppliers – working to ensure raw materials and component parts meet the company’s quality standards
  • Manufacturing teams – ensuring that equipment and processes follow predetermined quality standards
  • Customers – analyzing issues reported via customer feedback, maintaining records and implementing changes to manufacturing when necessary

Quality engineers will often be the individuals tasked with the creation of quality practices and documentation for a given product or facility.

They set out appropriate tests and acceptable result parameters to ensure that quality testing throughout the manufacturing process is effective.

Even at the point of troubleshooting, quality engineering is about more than just identifying problems – it’s about understanding the underlying issues and developing successful fixes, changing practices where necessary to ensure that standards are maintained.

What Does a Quality Engineer Do?

The role of a quality engineer can vary greatly between companies.

In larger manufacturing operations, quality engineers can have a specific focus or area of expertise (such as Quality Assurance Engineering or Quality Control Engineering – check out the links for more information about the differences in those areas).

In smaller operations, quality engineers can be tasked with a much wider remit of responsibilities, providing quality engineering support to the whole system.

Whatever the specific set up, quality engineers are working to ensure that manufacturing processes and ultimately, final products, meet both internal and external quality standards.

Based within the manufacturing facility, quality engineers can work on the manufacturing floor, in an office, or in a lab – depending on the specific tasks they are carrying out at the time.

As previously mentioned, specific duties of a quality engineer will vary from company to company. But as examples, they can include:

  • Creation of quality documentation and development of SOPs for their facility and products in line with industry standards
  • Proactive review and improvement of systems and processes to ensure maintenance of standards
  • Maintaining accurate quality documentation
  • Working closely with manufacturing staff to ensure quality protocols are followed and documentation is correctly maintained and implement any new changes or adaptations based on a quality review
  • Inspection and testing of various parts of manufacturing including products, components, processes, and comparing against predefined standards
  • Ensuring safety requirements are met at every point in the manufacturing facility
  • Analysing problems reported and developing improvements to overcome them
  • Oversight of junior quality team members
  • Statistical analysis of manufacturing data and creation of reports for senior staff members based on quality documentation
  • Working closely with external partners e.g. suppliers, customers, etc
  • Continuous improvement to the manufacturing process

Becoming a Quality Engineer

A Bachelors degree in a science or engineering discipline is the typical minimum requirement for quality engineering. An Associate’s degree with relevant experience may sometimes be enough to secure an entry-level role.

The ideal skill set for someone moving into a quality engineering role includes:

  • Analytical skills – need to be able to spot problems quickly and find the underlying causes so changes can be made
  • Critical thinking – once problems are identified, solutions and improvements must be found. This might involve thinking about a process, procedure or problem in a completely new way.
  • Attention to detail – as the people responsible for the creation and implementation of quality systems, as well as the people who notice and report on problems, every detail must be noticed and acted upon when necessary
  • Numerical skills – statistical analysis can be a big part of a quality engineering role
  • Communications skills – strong written and verbal communication skills are key. Must be able to relay potentially complex ideas to a wide range of audiences – both in personal consultations but also through company SOPs and quality documentation
  • Team working skills – working as part of the quality team, and in close coordination with other teams throughout the manufacturing facility (as well as potential for interaction with suppliers and customers) is a key part of quality engineering

Switch to Quality Engineering Roles in the Pharmaceutical Industry

If you want to know more about making a mid-career change into this area, take the first step with our 30-week academically accredited Certificate in eBioPharmaChem conversion course.

For more information on currently available Quality Engineering roles, head to our jobs boards and select Quality or Quality Projects in the “Jobs by Category” menu. We currently have jobs boards for Ireland, the UK, and Philadelphia, USA.

How Much do Quality Engineers Earn?

For information on typical salaries for this role, check out our Salaries Page.

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6 Comments

  1. Aryan March 9, 2018 at 01:18 - Reply

    Hi
    I am a mechanical engineer with 1 year quality assurance experience. What might be the entry position i might land into if I take up ebiopharma course.

    • getreskilled March 9, 2018 at 10:17 - Reply

      Hi Aryan,

      Truth be told, as you already have a mechanical engineering degree, you probably have enough to get your foot in the door in medical device manufacturing sector. Probably the only real barrier would be the lack of experience working in a GMP (Good Manufacturing Practice) regulated manufacturing environment.

      With the Certificate in eBioPharmaChem though, you’d be well positioned to target roles in the pharmaceutical manufacturing sector as well.

      You might check out this link on Salaries and Job Descriptions.
      https://www.getreskilled.com/pharmaceutical-salary/quality/

      • Aryan March 9, 2018 at 10:28 - Reply

        Thank you so much for the reply. Do you think my lack of experience could be countered by this certification?

        • getreskilled March 9, 2018 at 11:23 - Reply

          Well as mentioned, I’m not sure you’d be best served with it if you are targetting a quality role in medical device manufacturing. Just start applying for roles both for listed job openings and speculatively and see how you get on. Try and network with people from the industry and get their feedback.

          But sure, if you want to target roles with the pharmaceutical manufacturing industry, yes it’s going to help for sure.

          • Aryan March 9, 2018 at 19:34

            Pharmaceutical manufacturing is completely a deviation from my field i guess as it deals with only medicines wherein chemistry and biology jumps in. So is this ebiopharma course just for the pharmaceutical or for both pharma and medical equipment manufacture industry? As you have said i have looked for some roles in medical equipments field where GMP is required everywhere. So I still doubt just with my mechanical engineering degree would it be possible to land into medical field or is this course necessary.

  2. Ty May 10, 2018 at 22:54 - Reply

    Hey.
    My name is Ty and I am a Sr. Quality Reliability Engineer in Medical Sector. My customers are Abbott aka St. Jude Medical and about 10 others including Medtronic and Boston Scientific. I have the info you need to succeed in this field. I have been a Sr. Quality Engineet for Lockheed Martin Aerosoace as well. I’ve been in quality 12 years and a Sr Mfg Engineer 8 of those 12 years. It’s no joke man its alot of statistical matters so be inclined with graphs- xbar charts- minitab-excel-word-powerpoint-outlook-value stream-lean-plus alot more. You need to have at least 7 tests of quality experience to get in this boat. You would probably be a quality tech if you can hang them train your way to engineering tech to quality engineer. Then 5 years to 10 years later you can hopefully make Sr. Quality Engineer. But get that bachelors before that Sr title

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