Tokyo 日機装(株) ¥6,000,000 - ¥9,000,000
【仕事内容】

(No:101496)

開発保証部の管理職候補として製品(能動機器・非能動機器)設計開発フェーズにおけるQMS統括業務をお任せます。

【業務内容】

能動機器、非能動機器の設計QA業務全般を管理する立場として

以下の業務の管理者として対応していただきます。

・設計対象とするのは透析装置や関連消耗品

・設計や試験評価のスケジュールについて設計部署や外部試験機関との調整

・設計内容が書類手順通りのフローになっているかの確認

(品質マニュアルに則っているかの確認)

・設計や製造不具合時の調査から対策、再発防止策の検討。

・監査対応(社内監査年一回・社外認証機関年一回、計二回いずれも対応)

・薬事申請の関連については本社担当になるため、担当メンバーと共同で対応

・教育の計画スケジュールの立案(メディカル技術部門全体)

【担当製品】

主に透析治療に使用される透析装置、血液回路、ダイアライザー等がメイン

【海外出張について】

監査員として以下の拠点へ不定期に出張

工場・・・ベトナム、タイ、中国

その他・・(その他詳細は面談にてお伝えします)(その他詳細は面談でお伝えします)

【求める人材】

【MUST】

・医療機器QMSに関する知識(ISO13485)

・監査対応

【WANT】

・メンバーのマネジメント経験

・英語(読み書き程度)海外の法規制対応をお願いしたいため

・法規制対応の経験(その他詳細は面談でお伝えします)

【給与】

600~900万円

【勤務地】

東京都

【勤務時間】

求人紹介時に詳しくお伝えいたします。

【雇用・契約形態】

正社員

【待遇・福利厚生】

介護休職制度/資格取得奨励金制度/退職金/社員持株会制度/借り上げ社宅制度/財形貯蓄/社員寮(独身寮)/育児休暇制度

【休日・休暇】

土曜日/日曜日/祝日/年末年始休暇/夏季休暇/有給休暇/慶弔休暇/出産・育児休暇/完全週休2日制
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