Quality Engineering Manager

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Job details

Company overview

We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.

Responsibilities

• Contribute to cross-functional project(s) as engineering expert.
• Communicate with external manufactures to improve / develop the medical devices.
• Build strong relationship with external partners.
• Compliance with Quality Policy and regulations

Requirements

• 3 + years Knowledge of relevant Medical Device industry.
• Knowledge of design control and risk management for Medical Device.
• Experience of through the product lifecycle of Medical Device including pre-market and post-market.
• Experience in the manufacture for medical devices.
• Experience in the creation of Quality Management System documents.
• Expertise in the mechanical design, polymer material and manufacturing engineering for medical devices are plus.
• Understanding of relevant regulations and guidelines, e.g. ISO13485, ISO9001, ISO14971 FDA 21 CFR Part 820.
• Very good communication and problem solution skill among global cross-functional team.
• Strong Communication skill with external parties.
• Business level of English.

Salary

7 - 10 million yen

Location

Tokyo