Work Flexibility: Hybrid or Onsite 【Main Responsibilities】 ISO 13485およびQMS省令に基づき、品質マネジメントシステム（QMS）の構築・維持・継続的改善をリードし、各部門と連携して実効性のある運用を推進する 品質文書の管理体制を整備し、SOPの作成・改訂および教育を通じて、適切な文書運用と現場への定着を促進する グローバルの手順や要求事項を日本のQMSへ適切に展開し、国内規制との整合を確保しながら導入・運用を支援する 内部監査の計画策定・実施および是正措置のフォローアップを通じて、QMSの運用状況を評価し、改善機会を特定する マネジメントレビューに向けた品質指標および運用実績を取りまとめ、経営層への報告および改善活動の推進を支援する NC/CAPAプロセスの運用を推進し、不適合・逸脱に対する原因分析、是正処置の立案と実行および有効性確認、予防処置の立案と実行および有効性確認を関連部門と連携して行う 購買管理プロセスにおいて供給者の評価・再評価を実施し、要件を満たすサプライヤーの管理および管理体制の維持・強化を行う 第三者認証機関、規制当局（東京都庁・PMDA）およびCorporateによる監査・調査に対応し、準備から指摘事項への改善対応まで一貫してリードする 【Job Experience/knowledge/Skills/Competency】 ・医療機器QMSにおける業務経験5年以上 ・海外との業務遂行経験（必須ではない） ・医薬品医療機器等法及び関連法規制、QMS省令、ISO13485の正しい理解 ・ISO13485:2016の内部監査員資格（必須ではない） ・問題解決能力、論理的思考力 ・利害関係者との円滑なコミュニケーション力 ・日本語、英語（主にメール、必要時会議）Travel Percentage: None...
Team Manager - Order Management We are looking for a dynamic and inclusive Team Manager to join our team in Tokyo. As a Team Manager, you will lead a team of approximately 10-12 staff, taking charge of
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job CategoryCustomer Success Job Details About Salesforce Salesforce is the #1
Job Description: Business Overview Rakuten Group is based in Japan and serves approximately 100 million customers in Japan and over 1 billion globally. We provide more than 70 services in a variety of sectors, including e-commerce,
About Match Group Match Group is a leading global technology company focused on connecting people through a portfolio of iconic products, including Tinder, Pairs, and other brands used by millions of people around the world. We
About Match Group Match Group is a leading global technology company focused on connecting people through a portfolio of iconic products, including Tinder, Pairs, and other brands used by millions of people around the world. We
Act as leading & responsible supervisor for Maersk Customs services to acquire JP AEO status within expected timelines, and lead AEO management team before/after AEO license acquisition. We Offer We offer you an exciting international career that
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Purpose & Overall Relevance for the Organization Drive, manage and deliver the Go To Market (GTM) strategy against global priorities; lead category management team to bring the strategy to life as well as manage local team sports
General Information Job Advert Title: PV Reporting and Information Management Professional Location: Nihonbashi, Tokyo Division: Regulatory Affairs and Pharmacovigilance Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science
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Asset and Wealth Management, Operations – Alternatives Private Operations, Vice President, Tokyo Operations Operations is a dynamic, multi-faceted division that partners with all areas of the firm to deliver banking, sales and trading and asset management capabilities to
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企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
Job Description Are you interested in joining a team passionate about enhancing customer experience? We are seeking a highly skilled SAP key user to join us and help shape the future of one of the world’s
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Company:Qualcomm CDMA Technologies, Y.K. Job Area:Engineering Group, Engineering Group Systems Engineering General Summary: Job Description We are building the next generation of intelligent robots that operate safely and reliably in the real world. As Staff manager/Sr Staff