Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. The Quality Management System Specialist for Beckman Coulter Diagnostics is responsible for Maintenance and management of the quality management system. This position is part of the Beckman Coulter K.K., Global Business Quality Assurance & Regulatory Affairs located in Tokyo / Mishima and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time. You will be a part of the Quality Management System team and report to the Manager of the Quality Management System team responsible for Maintenance and management of the quality management system. If you thrive in a Quality Management System improvement role and want to work to build a world-class Quality management System organization—read on. In this role, you will have the opportunity to: + Conduct internal audit of the quality management system (as an internal auditor) + Support for external audits of the quality management system + Report and discussion to the person in charge of the quality process at the US headquarters + Conduct Communication activities of quality management system (Quality System Management Review/quality meeting + Conduct Quality management system process improvement (creation of procedure manuals and employee education) + Maintaining quality records The essential requirements of the job include: + Education: Bachelor’s degree + Experience: 5+years experiences in Quality field + Experience in maintaining and managing quality management system + Experience in quality-related work for medical devices or pharmaceuticals + Knowledge of the Pharmaceutical Affairs Low and related regulations + Work experience in English + Fluent Japanese skills It would be a plus if you also possess previous experience in: + Lead Auditor qualification for ISO13485 Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.