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Quality Assurance Senior Manager  品質管理マネージャー

Location: Tokyo Salary: ¥13000000 - ¥15000000 per annum + competitive
Sector: Quality Assurance (QA) Type: Permanent

To manage the Vigilance activity following to the regulation. (PMDA reporting and field action) through good strategy for the reporting to health authority.

Global Medical Device Manufacture (Cardiac Surgery, Neuromodulation, Cardiac Rhythm Management)

To manage product quality issue (Complaint, Failure analysis) through a good communication with Franchise QA.

To establish and maintain the QMS to align with the regulation and the Company global procedure

To assure the quality of the activity of outsourced warehouse and service company through the audit, monitoring etc.

To make appropriate/timely support for the requests from sales team including customer visit

To make effective QA organization by coaching the QA staff and resolve the issue and / or conflict.


Audit for:

Domestic suppliers

Subsidiary out of Japan

Oversea Company Distrubutor or Japan Distributors.

Education

- Bachelor's degree - preferred major: Engineering

Experience

- 3+ years experience in Quality Assurance for Class 3 or 4 Medical Devices under Japanese regulation

SThree Japan is acting as an Employment Agency in relation to this vacancy.