JPN_【QA】Specialist, Operation Quality

日付: 2022/11/30

場所: Tokyo, 13, JP

会社: Boston Scientific

Specialist, Operation Quality


Purpose Statement
・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.



Key Responsibilities
・Handle recall activity 
・Interface with 3rd party vendor including 3PL, distributors, and other suppliers to implement proper quality assurance post release.
・Assess manufacturing sites' operations to ensure adequate quality system controls and resolve quality issues. 
・Develop localization methodologies including local label design and manufacturing process for new and existing products.  Design and install processes, procedures, and statistical techniques
・Create and revise 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 processes and procedures with improvements.
・Interface with other engineering departments, manufacturing sites, customers, and suppliers on quality related issues in a timely manner.




・Over 3 years of quality related job in healthcare (medical device, pharmaceuticals)
・Knowledge of Japanese Regulations, ISO 13485 and ISO 9001.
・Ccommunication skills at global level with business level English
・Self-starter, able to proactively influence surroundings for creating more opportunities
・Conduct hands-on as well, not only concept/strategy

Boston Scientific