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, proposes improvements to
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,
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...
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
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Job Description: Business Overview Rakuten Groups basic management philosophy is to empower people and society through innovation”. We provide more than 70 diverse services, including EC services such as shopping malls and travel booking sites, financial
Job Description SummaryThe Logistics and Site Material & Quality Administrator is responsible for managing logistics, site material, and site-related and warehouse-related quality activities (i.e. shortage of materials or parts, defective material/parts handling, refilling of materials or parts, package
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,
Join ispace as a Propulsion Design Engineer and help shape the future of lunar exploration. We’re looking for a passionate engineer with broad experience in the mechanical design of spacecraft propulsion systems—someone excited about tackling complex technical
Founded in 1913 in Italy, the Prada Group was built on a tradition of excellence and with a vision of innovation. The Group, a world leader in the luxury sector, operates in more than 45 countries
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
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
About us Founded in 2017, Wayve is the leading developer of Embodied AI technology. Our advanced AI software and foundation models enable vehicles to perceive, understand, and navigate any complex environment, enhancing the usability and safety
Career CategoryQuality Job Description Help shape the future of quality at Amgen. At Amgen, every step we take is driven by a powerful mission—to serve patients. As one of the world’s leading biotechnology companies, we are committed
Location: Japan (Tokyo) Join Fortinet, a cybersecurity pioneer with over two decades of excellence, as we continue to shape the future of cybersecurity and redefine the intersection of networking and security. At Fortinet, our mission is
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
Company:Qualcomm Japan GK Job Area:Engineering Group, Engineering Group Software Applications Engineering General Summary: The Opportunity We are building the next generation of intelligent robots that operate safely and reliably in the real world. As Director of
About the job As Medical Quality Excellence within our Medical Affairs team, youll play a pivotal role in upholding ethical standards, compliance, and quality across our medical operations — helping shape a transparent and high-performing medical organization. Ready
Location(s) Yokohama, Kanagawa Company Molex Career Field Engineering Job Number 189592 Your Job As a Vision System Engineer, you will support global manufacturing sites by delivering practical, high-impact automation solutions. You will focus on enhancing inspection processes