JPN_【QA】Engineer, Sr Quality Job

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