What does a career in QARA demand?
In the first in our series on careers in the medical device industry, we spoke to our Quality and Regulatory Affairs Manager, Arnya Traher.
...it’s all about processes, problem solving and understanding what you need to do to implement differences in market requirements.Arnya Traher, Quality and Regulatory Affairs Manager
If you’re thinking of what to do with your biosciences degree, and you’re a pragmatist who likes an intellectual challenge, QARA could be a career path for you. For our QARA manager, Arnya Traher, her move into quality assurance (QA) and regulatory affairs (RA) has been a good one. The role challenges her, while still giving her the satisfaction of working on something that makes a real difference to people’s lives.
What does QARA involve?
“Overall it involves making sure that as a manufacturer we make high quality products and meet all the standards and requirements for the medical device – in our case stoma care pouches and accessories – in every market. This includes regulations around quality as well as things like labelling.
The quality assurance (QA) side is very practical. You have to follow processes and solve problems. How do you meet the quality requirements in the simplest way possible so that you hinder the manufacturing process as little as possible? Your quality processes span all the stages of production, from manufacturing through to research and development, design, supply, control and purchasing.
The regulatory side is more intellectually challenging. Each country has its own rules on labelling for example. Some will need greater vigilance, others more detailed instructions for use. I’ve worked with the FDA in the USA and its equivalent in China, and this was very useful. Sometimes the key challenge is finding out what the regulations are in English!”
How did you come to be where you are today?
“I did a biochemistry degree, and my first job was in an NHS dialysis unit. As part of the role I monitored bloods for people who were having or who had had kidney transplants. I developed a test to help determine the right level of a certain anti-rejection drug to give patients. Too much and it would poison the kidney, too little and it might be rejected by the patient’s body. I knew the patients I developed the test for, and this first job made me realise how important it was that my work link to real people. That it makes a difference to real people.
I then moved from the NHS into working in a medical technology/device company into R&D at a time when HIV was becoming an issue. From an R&D perspective it was a rewarding time to be involved in blood testing, because it was unknown and we needed to find solutions quickly on the manufacturing side.
Having experienced that I moved into manufacturing support, working on transferring blood testing products from the US to UK markets. We also developed and manufactured our own tests for cancer markers, hepatitis and heart disease markers amongst other things. In the end I headed up the quality department of the UK manufacturing site.
From there I came to Welland 2 years ago. It’s the other end of the spectrum in terms of medical devices, but the skills and experience are as relevant because it’s all about processes, problem solving and understanding what you need to do to implement differences in market requirements.”
Why should someone consider a career in QARA, and who do you think would do well in it?
“I have had a fabulous career. I’ve worked with people from across the world and made products that I am proud to know have made difference to people’s lives.
People who do well in QARA are those who enjoy a challenge and like being part of a team. You should enjoy analysing data, always be looking to make improvements, pay attention to detail and be able to cope with a varied workload. But most of all you need to have a passion for making quality easy to achieve and making the best products for people who need them.
Personally, my tenacity, pragmatism and sense of humour have served me well in QARA. That and my love of science and solving a problem in the simplest way possible. And being able to work well in a team. Quality assurance and regulatory affairs are always team efforts.”
If you like the sound of QA or RA or both, I would advise you to get a good grounding in a scientific discipline, such as biosciences, chemistry or engineering, either by education or by working in companies that support training, as this helps reviewing data and regulations that are often written in scientific language.”