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JPN_【QA】Engineer, Sr Quality Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Tokyo, JP

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.


Work Experience:

  • 必須要件:Over 3 years of Quality related job healthcare (医療機器業界でのご経験があれば、より望ましい)
  • Conduct hands-on as well, not only concept/strategy


Skills & ability(歓迎要件)

  • Knowledge of Japanese Regulations, ISO 13485 and ISO 9001.
  • 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


Boston Scientific

Job Segment: QA Engineer, Quality Engineer, Quality Assurance, QA, Senior Quality Engineer, Engineering, Quality, Technology

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