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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 are 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.

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 – analysing issues reported via customer feedback, maintaining records and implementing changes to manufacturing when necessary

Quality engineers will often be the individuals tasked with 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 [include link to QA Associate article] or Quality Control Engineering [include link to QC Associate article] – 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 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, the first step is our 30 week conversion certificate course eBioPharmaChem.

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, Philadelphia, USA and Puerto Rico.

How Much do Quality Engineers Earn?

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

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February 17th, 2017|