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
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
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...
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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
Job title - Quality Manager, Taste Location - Kitaibaraki, Japan As a Quality Manager, you will be responsible for overseeing all quality activities at the site, from receiving materials through to releasing products to customers. You will also be
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Responsibilities（Immediately after hiring) 1. Pre-check FCCB report 2. Summarize quality related KPI and report preparation 3. Assist engineers to summarize FCCB, SPC, Audit related KPI Minimum Qualifications 1. Ability to use excel for data summarization 2. Good
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