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JPN_【QA】Principal, Operation Quality

今すぐ応募する

求人に応募する

日付: 2022/01/15

場所: Nakano-ku, JP

会社: Boston Scientific

Principal, 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
・Develop and maintain supplier quality process. Perform supplier audit utilizing ISO13485/9001 expertise. 
・Perform failure analysis and resolve quality issues.  Perform and/or lead CAPA activities.
・Interface with 3rd party vendor including 3PL, distributors, and other suppliers to implement proper quality assurance post release.

 

 

Other Resposibilities

・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.

 

 

Qualification
・Strong understanding and experience of PMD Act, ISO 13485, ISO 14971 and ISO 9001.【必須】
・Over 5 years of Quality related job in a medical device company
・Strong communication skills at global level. Fluent in both English (Business level) and Japanese (Native level)
・Qualification of ISO13485 auditor is preferable.
・Strong analytical and problem-solving skills
・Dynamic leader and strong team player
・Self-starter, able to proactively influence surroundings for creating more opportunities
・Conduct hands-on as well, not only concept/strategy

Boston Scientifc