募集要項
- 募集背景
- 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.
- 仕事内容
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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.
- 応募資格
-
- 必須
-
Skills & Ability:
● Knowledge of Japanese Regulations, ISO 13485 and ISO 9001.
● Strong communication skills at global level. Fluent in both English (Business level) and Japanese.
● 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:
● Over 3 years of Quality related job healthcare (medical device, pharmaceuticals)
● Conduct hands-on as well, not only concept/strategy
- 雇用形態
- 正社員/Full-Time
- ポジション・役割
- Senior Operations Quality Specialist - Quality Affairs
- 勤務地
- Saitama Prefecture / Chiba Prefecture / Tokyo / Kanagawa Prefecture
- 年収・給与
- 8 million yen ～ 10.99 million yen
