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...
Role Overview The Real-Time Market Data (RTMD) team is responsible for operating and supporting the firms mission-critical market data infrastructure that powers electronic trading, risk management, and front-office applications globally. This position primarily supports North American trading
The Opportunity: As a Senior Systems Engineer, you will play a key role in our technical delivery team to drive the technology programs, including Cloud implementation and support, desktop engineering escalation and networking for a defined portfolio
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
Are you interested in playing an integral part in client management and innovation within our Equity Plan Management Team providing the opportunity to grow and develop your career within the equity space? This is the great opportunity for
Job Description Purpose of the role To build and maintain infrastructure platforms and products that support applications and data systems, using hardware, software, networks, and cloud computing platforms as required with the aim of ensuring that the
Mujin is a global leader in industrial automation, redefining supply chain efficiency through MujinOS—our intelligent operating system for robotics. At our core is Machine Intelligence (MujinMI), a unique approach that leverages real-time digital twins and advanced perception,
About Woven by Toyota Woven by Toyota is enabling Toyota’s once-in-a-century transformation into a mobility company. Inspired by a legacy of innovating for the benefit of others, our mission is to challenge the current state of
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About Woven by Toyota Woven by Toyota is enabling Toyota’s once-in-a-century transformation into a mobility company. Inspired by a legacy of innovating for the benefit of others, our mission is to challenge the current state of
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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
仕事内容 本ポジションは、ECU（Electronic Control Unit）におけるソフトウェア開発全体をマネジメントし、品質・納期・プロセス遵守を担保しながら開発チームの成果最大化を図る役割です。 要求・仕様管理、タスク進捗管理、変更・不具合管理、品質管理など、車載ソフトウェア開発に必須となるプロセスを統括し、グローバルチームやOEMとの連携をリードします。 また、プロセス標準化、グローバルコミュニケーション設計、チーム健康度・関係構築の推進など、技術・プロセス・組織マネジメントの三軸をバランスよく実行し、ECU開発の成功に貢献する重要な役割です。 ミッション ソフトウェア開発プロセスの統括 要求・仕様管理、タスク管理、品質管理、変更・不具合管理など、ECUソフトウェア開発の全プロセスを一貫して管理し、確実な成果物提供を実現する。 グローバル・OEMとの円滑なコミュニケーション推進 海外拠点やOEMと連携し、文化・言語ギャップを吸収しながら、情報共有と合意形成を円滑に進める。 プロセス標準化・品質向上の推進 ASPICE・ISO規格を踏まえたプロセス改善、成果物管理・構成管理をリードし、開発品質と効率を向上させる。 チームマネジメント・関係構築 役割定義、人材の健全性管理、チーム間協力体制の構築を通じて、強い開発組織を実現する。 ロケーション 関東（東京・神奈川） 在宅勤務はプロジェクトのフェーズにより許可 職務詳細 ソフトウェア開発管理 組織・役割管理（Governance & R&R） コミュニケーション管理（Communication Management） 要求・仕様管理（Requirement & Spec Control） タスク・進捗管理（Task & Schedule Management） 変更管理（Change Management） 不具合管理（Defect Management） 品質管理（Quality Management / ASPICE対応）
Job Description Renesas has repeatedly conducted M&As with various companies, and we are working on a big project to integrate the systems with similar functions used by each excompany prior to the M&As into a single common
About Us We are a bilingual Managed IT Services Provider (MSP) supporting foreign-owned and internationally focused companies operating in Japan. Our clients rely on us as their outsourced IT department, helping with day-to-day IT support, Microsoft
About Woven by Toyota Woven by Toyota is enabling Toyota’s once-in-a-century transformation into a mobility company. Inspired by a legacy of innovating for the benefit of others, our mission is to challenge the current state of
Job Description Position Overview The Specialist, Quality Systems & Compliance is an individual contributor who supports key GQP Quality Assurance activities on behalf of the Marketing Authorization Holder (MAH). The role plans and executes assigned quality tasks,
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
Join our team as a Client Advisor in the Japan Funds Business and be part of a dynamic environment where client satisfaction is paramount. This role offers the opportunity to leverage your expertise in financial markets