“With my knowledge and expertise, I audit and operate the forefront of standards and inventions”
Medical Health Service Division/Non Active Medical Products, Assistant Manager
The door to becoming an auditor opened for me thanks to my strong hope to contribute to society, using my experiences in design an development and gaining broader knowledge and experiences.
Previously, I was in charge of design and development at a manufacturer. About 10 years in, I realized that I want to work with more people and make use of my knowledge and experience for as many people as possible. During that time, at my workplace we had more and more audits, and I felt that this work was suitable as the next stage I was looking for. However, although I had knowledge of products, I did not have much experience in audits and laws and regulations, so I thought it would be impossible. But then someone reached out to me and I decided to join TÜV SÜD. It was also a great opportunity to work in a global environment, making good use of my English skills.
“We learn the fast-changing latest technologies and standards both overseas and in Japan and support the manufacturing process of our customers”- We, the auditors, are a group of professional experts for medical devices and strive to improve continuously.
Each audit project and the management of the customer are all left to the person in charge, so it is a responsible but rewarding job. Standards, laws and regulations, and technology change day by day, but our global training system is well-developed, and information can be updated in a timely manner. The annual qualification maintenance training is held together with auditors from all of our Asian entities. There, we can interact with auditors from various countries and experience and absorb different cultures and ways of thinking.
Regarding to our work style, the management of projects and clients are assigned to each member. Therefore, every auditor is responsible for his/her assigned project management, and feel rewarding to our missions. This responsibility brush up my professional excellence and make me to become expert. The standards and law regulations are changing from day to day that urge us to study and catch up. However, TÜV SÜD provides auditors fulfilling trainings in order to update latest information on time. For example, there are big global training provided regularly. In this training, ASEAN auditors are gathered once a year, and we can exchange and deepen understandings about diversity and different aspects.
If you If you have a strong desire to "learn and grow" by making use of your experience, you will be blessed with many opportunities at TÜV SÜD. have strong will to learn and grow, there are variety opportunities just behind you.
I was quite concerned, because I had no experience in audits, standards, or knowledge of laws and regulations, but you have the opportunity to learn at TÜV SÜD, so as long as you have the motivation and aspirations, you can grow as an auditor. In addition, product knowledge is also important, so almost all of our auditors had no previous experience in auditing before joining. We are waiting for those who want to take on challenges in a new environment and want to grow.
Medical Health Service Division/Non Active Medical Products
Of the 50 people in the MHS Division as a whole, about 20 people, including auditors and coordinators, are active in the Non-active Medical Devices Department.
*Specific business content
Non-active medical device quality management system auditors are responsible for certifying the quality management system required to sell a medical device. Mainly, you will be asked to evaluate the conformity with domestic and foreign laws and regulations and international standards (examination of ISO, CE marking, etc.) regarding non-active medical devices.
We proceed with projects while keeping in touch with our customers. The main job is to prepare for the audit, conduct the audit, and prepare a report afterwards. We also participate in overseas (Asia and Oceania) projects as well as domestic ones. In addition to that, we also carry out certification business for Japanese products. Training is also provided to expand and maintain the qualifications of auditors. Trainings are held not only in Japan but also overseas.