Kazuhiro Matsumoto / General Manager, Quality Control Department

Kazuhiro Matsumoto

Kazuhiro Matsumoto joined the company in February 1994 and was assigned to the Quality Control Department in the In Vitro Diagnostics Division at the Matsuyama Site. He then took roles as a quality management supervisor and a manufacturing process supervisor at the Wakimachi Site, before taking up his current role as a general manager of the Quality Control Department, where he oversees the quality management of the entire division.

What does your work involve?

I’m in charge of quality management across the entire division, including the creation of quality management systems that comply with ISO 13485. This management system covers the design validation process of new products, mass-production management and post-marketing surveillance and vigilance.

The Quality Control Department comprises three groups: the Quality Assurance Group, the Quality Control Group, and the Pharmaceutical Affairs/Safety Control Group.
The Quality Assurance Group is mainly responsible for design and development inspections and post-marketing vigilance. The Quality Control Group inspects incoming components and outgoing products, and performs statistical failure trend analysis. The Pharmaceutical Affairs/Safety Control Group manages market safety information and ISO standards, and ensures compliance with Pharmaceutical Affairs Law worldwide. These three groups work together to secure quality management across the whole division.

What is the most important thing to you in your work?

My priority at work is to ensure daily improvements as we seek to provide best-in-class precision—a goal that can be seen in our corporate vision. To achieve this goal, it is paramount that we combine outstanding design, parts, and manufacturing processes. Most importantly, every process, even from the design stage is reviewed and evaluated against high quality standards. We encourage front-loading concurrent engineering, bringing various departments in from the design and development stage to enhance product quality and shorten development times. This enables us to meet the diverse needs of our business partners, hospitals, clinics, and patients, which we think is most important.

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