Analyst, Quality Systems job opportunity at Edwards Lifesciences Corporation.

Home Jobs In Japan Tag: Quality Systems Analyst, Quality Systems position at Edwards Lifesciences Corporation


DateMore Than 30 Days Ago bot
Edwards Lifesciences Corporation Analyst, Quality Systems
Experience: General
Pattern: full-time
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Quality Systems

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degreeGeneral
loacation Japan-Tokyo HQ, Japan
loacation Japan-Tokyo HQ....Japan

エドワーズライフサイエンスは、構造的心疾患とクリティカルケアモニタリングの領域において、患者さんを中心にした医療イノベーションの世界的リーダーです。世界100カ国以上で数百万人の患者さんに医療技術を提供し、治療アウトカムの向上や、医療的アンメットニーズに対する持続的なソリューションを創出することに全力を注いでいます。 【業務内容】 社内ステークホルダーと協働して、法規制（特に薬機法および関連省令）およびISO 13485に基づく品質マネジメントシステム（QMS）の運用、医療機器の製造販売に係る以下の業務のいずれか若しくは複数をご担当いただきます。（担当業務は適性を考慮の上決定いたします。） 文書・記録管理 サプライヤー管理 トレーニング 医療機器／QMSの変更管理 QMSの改善 薬事関連業務、外部監査対応（QMS適合性調査を含む） 製品変更情報の評価 【必須要件】 メーカーにおける品質保証、特にISO 9001相当のQMSに係る知識、運用・維持・改善業務の経験：3年以上 Microsoft Word/Excel/Powerpointのスキル 英語力（海外とのメールでのやり取りやミーティングができるレベル（TOEIC 730点以上）） 【歓迎要件】 薬機法およびQMS省令、ISO13485の知識 医療機器メーカーでの品質保証業務経験 QMS適合性調査申請、外国製造所管理業務経験 （文書・記録管理）　ITシステムを用いた文書・記録管理の経験 （サプライヤー管理）　内部監査／サプライヤー監査／外部監査の実施経験、ISO9001審査員補、認証機関におけるQMS審査員の経験 Power App等アプリケーションを利用した業務改善

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