Published: 24 Feb 2020

Susanne Karg, Head of Quality Assurance and Regulatory Affairs at Elekta, speaks to the CQI about her latest achievements and how she's making her mark on the quality profession. 

Why did you choose to work in the quality profession? 

Susanne Karg: When I worked in marketing and sales for Fritz Pauker Ingenieure GmbH – a German mechanical engineering company – the need to establish a quality management system for our medical device customers and ISO 13485 certification became more and more relevant.  “Who can do it?” was the question, and this is when I was entrusted with the new project. 

For me, quality management is a daily creative challenge to look beyond one’s own role, to be involved in every area of the company, to communicate with people, to impart knowledge and obtain opinions. I’m an advocate for our patients by implementing international rules for the safety of our medical devices that are used in cancer treatment (radiotherapy). 

I’m also a teacher and motivator for our employees where I communicate quality standards and, above all, the reason for all the effort which is to make patients’ lives better!

What would you say is the biggest achievement in your quality career so far?

SK: Professionally, of course, the achievement and maintenance of important certificates and country approvals (eg, Medical Device Single Audit Program (MDSAP), ISO 13485, Medical Device Directive (MDR) 2017/745/EEC, The Food and Drug Administration (FDA) in the US, and the National Medical Products Administration (China) is very important. Each certificate is a confirmation of the good quality work of the whole team.

Personally, knowing that my daily work is contributing to make the treatment of patients safe and effective. It is important to understand the negative chain reaction that can be triggered by a defective medical device in a hospital. Reliable medical devices avoid stressing patients and hospital staff.

Are there any role models in quality who have helped you progress in your career? 

SK: I don't really have a ‘role model’, but I have met many great and successful women who are extremely goal-oriented, focused, and great managers. 

Many women are very organised and often have the gift of reading between the lines. This makes them predestined for leading roles in quality management.

Why do you think we need more women working in the quality profession?

SK: I believe that women are particularly good mediators. Translating the demands into ‘human-readable text’, conveying acceptance and a deep understanding of the activities is a strength of many women.

Where do you see yourself in five years’ time? 

SK: The feeling of doing a good job and being a reliable and trustworthy partner for my colleagues is what I want to maintain. A good work-life balance is very important to me, and I want to be able to combine both of these together. We will see where that leads. 

What advice would you give to other women in quality who are looking to progress into more senior roles? 

SK: The only thing that often prevents us women from taking on ‘senior roles’ is either too much modesty or the question of how to reconcile this with children and family. If someone really wants to make a career, there are no limits for me. In the end, it’s the qualification that counts. 

I would advise women to apply for senior positions, be courageous, have confidence in their abilities, showcase their talents, and don't leave the successes to others.