Quality Engineers

The majority of quality assurance or quality control roles for those with an engineering background will be in medical device manufacturing as there is a much broader use of discrete manufacturing. Pharmaceutical and biopharma may have a few roles but the majority (but not all) tend to be concentrated around packaging operations. 

If you came into quality from a mechanical engineering or plant engineering background, you could also look at environmental quality roles.  Pharma needs purified water and clean air systems to manufacture safe medicines which are used for injections and part of your job would be to maintain and ensure the quality of the output of these systems. 

Apart from “Quality Engineer” or “Senior Quality Engineer”, here are some of the more common job titles we see advertised.

  • Senior R&D Quality Engineer
  • Design Assurance Quality Engineer
  • Quality Engineer – New Product Development
  • Principal Supplier Quality Engineer
  • Quality Engineer – Manufacturing Support
  • Senior Manufacturing Quality Engineer
  • Quality Engineer (QMS)
  • Quality Assurance Engineer
  • Quality Systems Engineer

NOTE: The majority of Quality Control roles in pharmaceutical manufacturing (and food processing) involve laboratory testing and for that reason, the majority of QC roles in the pharma sector tend to be filled by those with a lab/science background, not engineering/manufacturing backgrounds. 

You would have roughly 2 broad options.

Option 1

Retrain for production quality roles within a GMP regulated medical device manufacturing environment.

Take our 15-week online Conversion Course into Engineering Roles in Pharma to learn GMPs and how safe medicines and medical devices are made in a regulated environment. You will also learn the air, water and steam systems that underpin medical device manufacturing.

Option 2

Retrain for environmental quality roles within a GMP regulated manufacturing environment.

Take our 15-week online Conversion Course into Engineering Roles in Pharma 

As a quality engineer, you’d be well placed to work in environmental quality roles within both the pharmaceutical and medical device manufacturing space. Pharma needs purified water and clean air systems to manufacture safe medicines which are used for injections. These aseptic processes have to be designed, validated, monitored, maintained and updated in FDA regulated manufacturing facilities. 

You will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpin an aseptic manufacturing facility and the quality systems.

Then take our 10-Week Online Starter Validation program to learn how those systems are validated.