Develop, implement, maintain and improve appropriate quality system elements to ensure the high quality level of new and existing products. Works with problems of moderate scope where the analysis of a situation or data requires a review of identifiable factors.
[Main business responsibility]
-Provide Quality Engineering support for sustaining activities and improvement projects for commercial products: Business Continuity, Value Improvement Projects (VIP), Non-Conformance Event Prevention (NCEP), Correction and Preventive Actions (CAPA).
-Assess product configuration, design, process, and supplier changes: Design Change Analysis Form (DCAF), Change Analysis Form (CAF), and Supplier Change Impact Assessment (SCIA).
-Assess manufacturing sites’ operations to ensure adequate quality system controls and resolve quality issues. Achieved through virtual meetings, phone calls, emails, or other change request methods.
・ Develop localization methodologies including local label design and manufacturing process for new and existing products. Design and install processes, procedures, and statistical techniques.
・ Perform quality trending using the NCEP / CAPA system. Perform failure analyzes and defect investigations. Resolve quality issues and approve material dispositions. Perform and / or lead risk analyzes and failure investigations for CAPA and / or audit findings investigations.
・ Create, revise, and approve departmental procedures.
・ Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.
・ Design and / or implement Quality System improvements.
・ Interface with other engineering departments, manufacturing sites, customers, and suppliers on quality related issues in a timely manner
[Required experience / ability]
・ Strong communication skills at global level. Fluent in both English (Business level) and Japanese (Native level).
・ Strong analytical and problem-solving skills
・ Dynamic leader and strong team player
・ Self-starter, able to proactively influence surroundings for creating more opportunities
・ Work experience in health care (medical device, pharmaceuticals)
・ 3 years of Quality or Regulatory Affairs related job is preferred
・ Conduct hands-on as well, not only concept / strategy
・ Headquarters (Nakano-ku, Tokyo)
・ Preferential treatment in consideration of previous job
・ Scheduled working hours 9: 00-17: 30 (including breaks 12: 00-13: 00)
・ The company may order overtime and holiday work due to business reasons.
Saturdays, Sundays, and holidays, paid leave, summer vacation (5 days), year-end and New Year holidays (12 / 29-1 / 4), injury and illness leave (5 days), long-term service leave (5 days every 5 years of service), etc.
Medical expenses subsidy at admission, long-term income support insurance, regular health checkup (day trip human dock for 35 years old and over), self-development support system (up to 100,000 yen / year), employee stock ownership, various congratulatory money, benefit station (membership welfare) Welfare discount service), selective welfare points worth 100,000 yen per year (additional insurance, additional self-development, sports club expenses, home computer purchase assistance, eyeglass purchase assistance, theater / concert / movie viewing cost assistance, etc.)