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This posting is managed by: | IT JOBs in Japan |
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Company Name | Company is not publicly visible |
Job Type |
Manufacturing (Automobile/Plant Engineering/Precision Equipment) - Quality Control
|
Industry | Automotive and Parts Manufacturing |
Location |
Asia
Japan
Tokyo
Shinagawa
|
Job Description |
[Business content] ・Maintaining ISO13485 certification for Japanese development bases ・QMS Support for overseas bases (FDA/CE/NMPA) ・Create and maintain Risk Management File ・Administrative report (if any) ・Negotiations with external testing laboratories [Recruitment background for this position] In the quality department, improving product quality on a global basis has become an important mission as mobility sales volume and sales countries expand. As we expand our business, we are looking for people who can handle product certification procedures globally and people who can utilize their language skills to maintain quality management systems at our bases in each country to join our legal and regulatory certification department. We believe that you will be able to gain a wide range of experience as we not only provide "electric wheelchairs" for medical and welfare equipment, but also provide self-driving services and rental services for large facilities. In addition, the quality department has particularly strengthened its organizational structure in recent years with an eye toward business expansion and global expansion. This is a position where you can experience the growth of the company's brand and the improvement of quality with your own hands. |
Company Info |
[Future business structure] Our mission is to "make transportation fun and smart for everyone," and we provide short-distance transportation solutions for pedestrian areas, airports, and commercial facilities. In order to meet the needs of airports and commercial facilities, we offer a self-driving service that provides services using aircraft equipped with self-driving functions, and a corporate rental service that rents out aircraft that users can freely drive directly from commercial facilities and shopping centers. In addition to direct sales through our online store, we also have agency sales channels such as nursing care goods stores, automobile dealers, and home electronics retailers in Japan, and we offer a variety of models such as the Model C2, Model F, and Model S. We are developing our business with two pillars: the "mobility sales business," which sells products around the world. We operate mobility sales and service businesses in more than 20 countries, regions, and regions, not only in Japan but also in North America, Europe, and APAC, and we will continue to strengthen our global structure. |
Working Hours |
Flextime system (core time 11:00-15:00) Remote work possible. (May come to work about twice a week if necessary) |
Job Requirements |
【Prerequisite】 ・Understanding of ISO 13485 requirements and ability to respond to external audits ・Ability to maintain and manage quality management systems (document management, operational management, internal audit) ・Communication skills (both English and Japanese at business level) [Welcome conditions] ・Knowledge of quality management system MDSAP method and audit experience ・Experience in product certification procedures and technical document creation ・Knowledge of medical device electrical safety testing ・Knowledge of biocompatibility, software development process, usability engineering, and documentation ability |
English Level | Business Conversation Level (TOEIC 735-860) |
Japanese Level | Business Level(JLPT Level 2 or N2) |
Salary | JPY - Japanese Yen JPY 6500K - JPY 8000K |
Other Salary Description |
Fully equipped with social insurance |
Holidays |
Complete 2-day week (Saturdays, Sundays, and public holidays) Complete 2-day week (Saturdays, Sundays, and public holidays) summer vacation winter vacation paid holiday |
Job Contract Period |
full-time employee |