JPN_【QA】Engineer, Sr Quality Job
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
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QA Engineer, Quality Engineer, Quality Assurance, QA, Senior Quality Engineer, Engineering, Quality, Technology