Job Information
Danaher Corporation RAQA Manager in Tokyo, Japan
For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.
Leica Microsystems is one of the market leaders in the fields of microscopy, imaging, and analysis. We reveal the invisible and empower our customers to create a better and healthier world. Together with our customers, we transform scientific discovery. We empower surgeons to take well-informed decisions in life-changing procedures. We enable users to gain insights which help answer key questions concerning development and engineering. All of this is achieved with the combination of cutting-edge microscopes and AI-based image analysis.
Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.
Leica Microsystems is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
We currently offer the following position in our office in Tokyo, Japan which will be hybrid.
RAQA Manager
YOUR RESPONSIBILITIES
Act as the Management Representative for Leica Microsystems (LMS) Japan during external audits.
Serve as the RAQA business partner for internal stakeholders and ensure LMS Japan processes comply with Japanese regulatory requirements.
Ensure compliance of LMS products and processes with the Quality Assurance Agreement between LMS Japan and legal manufacturers.
Develop RA strategies for new products to ensure timely regulatory approvals in Japan and communicate regulatory requirements to stakeholders.
Establish relationships with government agencies and internal stakeholders at Leica Microsystems; train LMS associates on Japanese regulatory requirements.
Apply CAPA and other continuous improvement tools, and keep abreast of Lean Management and Continuous Improvement tools like 5S, DMP, SW, and TPI to ensure high standards of process and product quality.
Adhere to company EHS requirements and risk assessments; meet the requirements to be SOKATSU, with extensive experience in regulatory affairs, quality assurance, and MHLW regulations, along with strong teamwork, interpersonal communication, analysis, judgment, negotiation, and conflict resolution skills.
YOUR PROFILE
Education: Minimum bachelor’s degree in engineering or Life Sciences. Advanced degree for medical test, laboratory medicine, medical engineering, chemistry, biology and pharmaceutical or above is preferred.
Work experience: Extensive relevant experience in Regulatory Affairs and Quality Assurance at Medical Device companies in Japan. More than 3 years’ experience on similar managerial position.
Required Skills: Track record in management positions with demonstrated problem solving and continuous improvement skills.
Languages: Native Japanese, Fluent English – spoken and written
At Leica Microsystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Microsystems can provide.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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.