Quality engineering is vital to many products that shape our lives, including pharmaceuticals. It helps ensure that quality assurance and control, along with validation and verification, are being met, allowing consumers to be entirely insulated from harm due to poor processes.
Below, we’ll explain more about what quality engineers can do for pharmaceutical manufacturers.
What does a quality engineer do?
A quality engineer is responsible for ensuring that products meet high-quality standards. They are responsible for developing processes and procedures, testing them, and implementing new systems to ensure that all medical equipment and medications comply with safety regulations and meet consumers’ expectations.
With quality engineering, quality products are always the goal. This starts with the initial product design through the manufacturing stages, where a quality engineer oversees it. Quality engineers play a crucial role in pharmaceutical manufacturing because they ensure everything is up to the highest standard.
To ensure standards are being met, quality engineers perform routine quality checks on products and create preventative measures that help mitigate defects and achieve high-quality products every time.
What are the responsibilities of a quality engineer?
Quality engineers are responsible for the overall quality of manufactured products. Some everyday responsibilities that quality engineers can expect to have working for a pharmaceutical manufacturer include:
- Establishing and implementing quality standards
- Monitoring workflows, processes, and products
- Create quality and thorough documentation
- Collaborate with operations managers to identify workflow improvements and controls to ensure workers are complying with health and safety codes and regulations
- Testing and inspecting processes to ensure they exceed standards
What education is required for quality engineers?
To become a quality engineer, you need a balanced education, training, skills, and experience. Here’s a closer look at the process:
- Get your degree: Quality engineers must have an associate’s degree in quality engineering at a minimum. However, some senior positions require that you have a master’s degree in quality assurance. During your education, you’ll learn the basics of quality assurance, including local, state, and national regulations, documentation, and testing processes.
- Get experience: Before you get certified as a quality engineer, you’ll need to build experience in the field. You can get experience in college with an internship or an entry-level position to learn the ropes.
- Get certified: After you have the necessary degree for the job, you can get your quality engineer certification from the American Society for Quality. The exam you will need to take covers topics like management and leadership, the quality system, product and process design, product and process control, continuous improvement, and risk management. Once you obtain your certification, you will need to renew it every three years to ensure that your knowledge is up to date.
What skills do you need to be a quality engineer?
Hard and beneficial skills you will need to be a quality engineer include:
- Time management
- Mathematics
- Communication
- Technology
- Critical thinking
- Attention to detail
Bothwell Engineering: Biotech Engineers Prepared to Make Your Project a Success
Whether you need an expert with knowledge of current industry regulations or help managing projects, Bothwell Engineering offers biotech engineering services that can help your manufacturing or startup project be a success.
We can provide your facility with the team of industry experts you need to take your project from development to commissioning and are committed to providing a solution that meets your unique needs.
Get in touch with us today!
