Job Information
Danaher Corporation QA Specialist 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 Yokohama which will be hybrid.
QA Specialist
Come join a fantastic team! This is a very interesting position located in Yokohama and reports to Senior Manager RA/QA Japan.
YOUR RESPONSIBILITIES
Act as Quality Specialist or Sekinin-Gijutsusya / Kokunai-Hinseki to ensure requirements of Quality Systems ISO-13485, PMD_169 and other relevant guidelines requirements are implemented and maintained.
Develop & enforce Quality Systems to assure Product/ Services Quality requirements and customer satisfaction are met in Japan.
Ensure adequate planning of the quality management system and how the requirements for quality will be met. Ensure that the integrity of the Quality Management System (QMS) is maintained when changes to the QMS are implemented.
Ensure that appropriate communication processes are established and maintained which include communication regarding the effectiveness of the QMS, establish communication processes with customers in relation to: Product information, Inquiries, contracts, or order handling, including amendments.
Standardize, and align Japan Quality Assurance practices with the global Corporate HQ processes.
Manage and/or ensure the specified requirements of the following systems/areas are met: document control, external provider control, record control, calibration, corrective and preventative actions (CAPAs), change control, customers complaints, customer feedback, internal auditing, logbook/notebook control, validation protocol, training, proficiency testing, equipment control, reference standard/reference material control, data review and reporting, disaster recovery, and safety.
To ensure applicable licenses, agreements, certificates are properly maintained. Provide support and coordination with cross-functional teams to ensure compliance with applicable Japan regulatory requirements.
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: Minimum 35 years QA experience in medical device company.
Experienced in transforming and improving Quality processes, systems, and culture with a demonstrated track record of process and productivity improvement and successful results with developing and implementing change initiatives.
Required Skills: High attention to detail and follow-through on commitments, Ability to work unsupervised.
Language Skills: Native Japanese, Fluent English – spoken and written.
WHAT WE OFFER
Attractive Benefits (Social Insurance, Labor Insurance, Company Pension, etc.)
Competitive Salary (decided by Experience and Actual Achievement)
Continuous training, support and focus on your personal development
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.
GET MORE INSIGHT
Learn more about what we do and who we are by watching our company video “We Are Leica”: https://www.youtube.com/watch?v=1zHmalqMXN4
Are you interested to discover new opportunities in an innovative, team-oriented environment? Do apply online - we are looking forward to your application!
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.