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
This role supports the quality management system for manufacturing operations. Responsibilities include maintaining and improving the quality management system, creating and revising SOPs in accordance with ISO 13485, QMSR and GMP requirements, and implementing related processes.
The specialist supports regulatory audits, including audits by notified bodies and the US Food and Drug Administration, and helps prepare responses and corrective actions. The role also involves compiling and analyzing quality data such as complaints, nonconformities and measurements, preparing reports, and implementing appropriate actions including shipment holds when necessary.
Additional duties include supporting continuous improvement activities such as CAPA, identifying quality issues and improvement opportunities, implementing corrective and preventive actions, conducting risk assessments, and carrying out quality investigations. The role also supports supplier quality management, including quality agreements with external partners and the management of supplied services and components.
Applicants are expected to have at least three years of experience in quality assurance for regulated products, preferably including experience maintaining a quality management system. Experience managing multiple projects is preferred. Business-level Japanese is required. English communication with global members, proficiency with Excel and PowerPoint, presentation skills, project management experience, communication and coordination with multiple stakeholders, strategic thinking, problem solving, adaptability, and the ability to make decisions are listed as qualifications.
The position is a regular employee role. Working hours are 8:40 to 17:25, with a 12:10 to 12:55 break. Flextime is available, with exclusions depending on employment conditions. Hybrid work is possible, and the posting states that office attendance is generally expected three to four days per week. The work location is in Tokyo, with other domestic locations potentially possible depending on business conditions. The posting states that the position is expected to involve two to three days of business travel per month. Benefits include 129 annual holidays, annual paid leave, social insurance and other company benefits.
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