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Job Details

POSITION SUMMARY:

• The desired candidate will have prior experience as a Senior Quality Engineer in healthcare field, preferably at a medical device company, to handle QMS system under PMD Act. Working with supervisor and team with good communication skill and teamwork

RESPONSIBILITIES AND ESSENTIAL DUTIES:

• Manage products quality with special knowledge of related Japanese laws, PMD Act, QMS Ordinance and GVP Ordinance and better experience with superior and/or team.
• Support managers (inc. managers of MAH) to handle QMS.
• Handle customer complaints with team. Perform investigations with communicating with related team/people like manufacturing sites, customers and etc. and data analysis with understanding risks.
• Manage nonconforming products. Open and close CAPA.
• Support superior to respond to Government and working with team.  
• Facilitate the execution of Risk Management activities in Japan with team.
• Support to create/revise documents, change control and document management for QMS.
• Participate in internal and external audits.
• Perform other Quality System related tasks.

DESIRED SKILL:

• Minimum of Bachelor’s degree
• 5+ years Quality Engineering experience in a manufacturing or industrial environment.
• Knowledge of PMD Act, QMS, GVP, GXPs and ISO13485.　　　　
• Certified Quality Auditor
• Familiar with other laws in Japan like CSCL, ISHL and etc.
• Language: Japanese and English - business level. (TOEIC SCORE :730)
• Good communication skill and teamwork

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