商社 / 生産管理/品質管理(機械/メカトロ) / QA　Specialist(Manager候補）

Essential Duties and Responsibilities

・Build, maintain, and improve QMS in accordance with QMS Ministerial Ordinances and ISO13485.U.S.A. and France in cooperation with the Quality Assurance Department, Alphatec Spine, Inc.

Experience/Capability

・MUST to have: At least 3 years of work experience in quality assurance or similar work at a foreign-affiliated medical device/pharmaceutical/in vitro diagnostics manufacturer, and work experience in collaboration with overseas HQ

・Nice to have: Work experience in building a QMS in accordance with the QMS Ministerial Ordinance and/or ISO13485

・Nice to have: Experienced working with X-ray diagnostic related products

・English proficiency, not only reading and writing but also attending conference calls and having a minimum conversation

このポジションは新しく導入する大型レントゲン診断機器のEOSを現行ディストリビューターから移管してQMSを構築する業務が最初のメイン業務になります。その際にはUS本社とEOSのQMSを立ち上げて行く必要があります。

レポートラインは日本法人社長。