#FutureInYourHands – This motto properly describes how TÜV SÜD empowers its employees. It’s best to hear from TÜV SÜD executives and staff members what their personal experiences are working for TÜV SÜD.
Can you describe your role within TÜV SÜD?
I work in Medical and Healthcare Services (MHS) as a Technical Lead Auditor for medical devices. I’m a point person for many clients to support their conformity assessments, assessing medical device manufacturers on behalf of governing bodies for quality management systems and product quality/safety via manufacturing facility audits.
What do you enjoy most about your role?
I enjoy the pace; it’s very fast-paced. There’s a lot to learn about our internal tools, what we need to do to help our clients comply with the regulatory schemes, what compliance means for them and the overall impact conformity assessment has on our community.
We are a very matrixed organization, so I also like the collaboration that comes with that. I enjoy working with clients, regulatory bodies and internal clients.
How did you choose this career path?
There were a lot of factors in place that led me down this career path. The most impactful was when I was about seven years old, my father was injured in an accident. His injury showed me the importance of regulating medical devices for quality and safety. My father’s treatment and recovery experience drew me towards the field of medicine and engineering. I pursued Bachelor’s, Master’s, and Ph.D. degrees in the engineering field, and a career in the medical device industry. My mother, good teachers at school and international educational experience also influenced my choice of this career path.
I began in medical device research and development (R&D). The hands-on experience that I gained through the R&D side of medical devices led me to the compliance side of the field, and it made me feel comfortable taking on my current role. Having the experience seeing a medical device evolve from a concept to a finished product has helped me in my role at TÜV SÜD. When I conduct conformity assessments, I know what I’m looking for and where to find those pieces in a manufacturer's quality management system.
Are there any challenges you've faced during your career that have taught you important lessons?
Keeping up with changing regulations in the industry by far has been the most challenging to keep up with. Upskilling to stay current with constant changes at faster pace is necessary to continue to contribute to the community for decades in a row. Learning has been an ongoing process. Information in form of guidelines and publications has become very accessible with technology. Discipline and focus has been key towards continuing to grow in the last decade for me.
Given your extensive experience in the medical device industry, how do you think the medical device industry will change over the next few years?
The medical device industry is here to stay and grow. With aging population what I expect to see is growth in 5 major areas. In no particular order, I expect to see an increase in industrial technologies innovation to make currently used medical devices more affordable, better in quality and minimally invasive. The second area is synthetic organs/tissue and combination devices. Synthetic tissue and organs are classified as medical devices and combination devices are medical devices combined with human or biological derivatives or pharmaceutical drugs. Third area is in the field of decentralized care where medical devices continue to move from hospital-based use setting to mobilized setting, home based usage, self-care use and telemedicine. Fourth area is demographic-oriented technologies like pediatric technologies, aging-related devices and enhancement/augmentation devices. Lastly, the area of data management and protection. Medical device companies will continue to handle a lot of post market surveillance data requiring vast improvements in cybersecurity, wireless systems and IT infrastructure.
When not working, how do you spend your spare time?
I spend it outdoors with my husband and daughter. We enjoy hiking and bicycling, and anything that will keep us outside. We also like traveling.
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