Lead cross-functional medical device development projects from concept and market analysis through manufacturing, commercialization, and post-launch improvements. Manage schedules, risks, resources, budgets, and QCD targets while coordinating R&D, quality, manufacturing, marketing, procurement, and service teams.
About this role
The Design Quality Engineer participates in product design and development as a member of the quality assurance organization. The role establishes design-quality processes and requirements, supports development teams in maintaining design-control documentation, and helps ensure product quality throughout development.
Responsibilities include risk-management activities for new products in cooperation with R&D, manufacturing, regulatory affairs, and other related functions. The role conducts design-risk evaluations and provides feedback on products developed globally. It also contributes to quality strategy for compliance and supports the delivery of safe and reliable products.
Required experience includes work related to electrical, mechanical, software, or other engineering fields, or experience in quality-related work. Experience with design controls is required, including design input and output, verification and validation, design transfer, traceability, and design history files. Experience with risk management and FMEA, test methods and validation, or statistical quality-control methods such as SPC, Six Sigma, AQL, and sampling is also required in one or more areas.
The posting requests the ability to prepare reports and make presentations, project-management skills, and English ability equivalent to a TOEIC score of 600 or higher for reading and writing documentation and communicating by email. Preferred qualifications include experience with electrical design and QMS, advanced knowledge of statistical quality control, process mapping and analysis, and experience using product-quality-system documents such as DMR, DHR, and labeling materials.
The position is based at the Hachioji headquarters in Tokyo. Work may also take place at a satellite office, a customer site, or another office, and the work location may change depending on business needs. Working hours are 8:45 to 17:30 with a 45-minute break and an expected eight-hour workday. Flextime is available, with certain restrictions, and short-time work may be available. Social insurance, annual paid leave, and other benefits are provided according to company rules.
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