To perform Domestic Quality (QMS) Manager required by Pharmaceutical and Medical Device act.
Essential Duties and Responsibilities:
・Supervises and manage Quality Engineers by providing leadership, development, training and create positive work environment to ensure high productivity, employee engagement and performance.
・Responsible for staffing, positioning, hiring and disciplinary action (as necessary).
・Establish Device Master File per each approval file etc. Maintein Device Master File up-to-date, if the approvals are changed.
・Establish SOP’s based on QMS(Ordinance 169), and revise them as necessary. Manage SOP’s based on related procedures.
・Inspect products and make records such that it conforms to standards as per the approval documents,
・Handle a complaint, after taking necessary measures. Investigate it in Japan as necessary, and when a customer requests investigation report, create the investigation report for the customer based on the investigation results
・If a problem occurs in the quality management system, investigate and correct the cause of the problem, and take measures to prevent its occurrence as necessary.
・If there is any doubt about the quality of the product, investigate the problem and take appropriate measures such as bonding the product and investigating the cause.
・If AJ conduct a recall action, Manage the recall action according to the PMD act.
・Decide release to market by lot and prepare records of the decision result
・Manage any quality related product changes and take action when needed.
・Collect information on quality of the products from domestic and abroad. When the information concerned is obtained, rapidly report in writing to the general marketing supervisor of medical devices and to make necessary and appropriate measures be taken.
・Performs the duties of the head of domestic quality operations required by law.
||Education and Experience:
・High school or higher, learning chemical, physics, biologics or engineering is preferred
・3 years or longer experience of Domestic Quality (QMS) Manager is preferred
Knowledge and Skill Requirements/Specialized Courses and/or Training:
・Knowledge about Pharmaceutical and Medical device act
・Knowledge about basic analytical technique
Machine, Tools, and/or Equipment Skills:
PC skills (MS Office: Word, Excel, Outlook)
To identify root cause of problem
Language and Communication Skills:
Good English communication skill
Coaching and interpersonal communication skill