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...
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
Job Description: Business Overview Rakuten Group provides over 70 services in a wide variety of fields, including internet services such as e-commerce, travel, and digital content; fintech (financial) services such as credit cards, banking, securities, electronic
Are you looking for a unique opportunity to be a part of something great? Want to join a 17,000-member team that works on the technology that powers the world around us? Looking for an atmosphere of
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
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
Job Description: Department Overview We aim to resolve challenges for corporate clients through the provision of Rakuten Mobile and other Group assets, while maximizing revenue across the Rakuten Groups corporate business. We build and operate CRM
Job Title:Quality PMO(Project Management Office) Summary: Driving and managing quality projects Ensuring alignment with Quality Management Systems (QMS) Cross-functional collaboration Supporting audits and management reviews Responsibilities Include: The Quality Assurance PMO assumes the following roles: 1) Driving and managing quality projects Managing schedules, progress, and
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
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Job Description: Department Overview Our division operates “Rakuten 24, Rakuten 24 Drink Museum, Rakuten 24 Health Care Museum, etc.”, a service that specializes in daily necessities, at Rakuten Ichiba, Japan’s largest online shopping mall. “Rakuten Ichiba”
Job Description: Department Overview Rakuten Ichiba is one of the largest e-commerce shopping centers in Japan with approximately 60,000 stores opening and a total annual distribution of approximately 6 trillion yen in 2024. It is a
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
Job Description: Business Overview The Technology Platforms Division (TPD) drives the growth of Rakutens ecosystem by delivering innovative, high-quality technology platforms characterized by integrated control and strategic partnerships. Within TPD, the Cloud Platform Supervisory Department (CPSD) develops
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
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
ESR is seeking an experienced Development Director to lead site prospecting and land acquisition for both Solar PV and Battery Energy Storage System (BESS) projects in Japan. This high-impact role drives full lifecycle development of large-scale renewable
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