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...
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
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
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
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
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
Driven by the passion to improve quality of people’s lives, WSA continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want
Job Description: Business Overview Rakuten General Insurance Co., Ltd. is a non-life insurance company within the Rakuten Group, Inc., seriously aiming to become the industry leader in auto insurance. We offer unique services that maximize the
Job Description Systems (80% - 90%): - Leverage strong technical knowledge of our existing high-side switches portfolio, deep understanding of the technologies, standards and protocols within an industry or end equipment, and an ability to engage with customers
Kenvue is currently recruiting for a: Brand Manager, Consumer Health Brand Management What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a
ispace is seeking a highly motivated and talented Senior Flight Software Systems Engineer to join the System Design Group under the Global Design division, responsible for the design and development of lunar landers and other transportation and/or communication/navigation
ispace is seeking a highly motivated and talented Senior Propulsion Systems Engineer to join the System Design Group under the Global Design division, responsible for the design and development of lunar landers and other transportation and/or communication/navigation platforms.
ispace is seeking a highly motivated and talented Senior GNC Systems Engineer to join the System Design Group under the Global Design division, responsible for the design and development of lunar landers and other transportation and/or communication/navigation platforms.
Join our Team About us Ericsson is opening a state‑of‑the‑art R&D center in Yokohama focused on Radio and Software development. This new hub will support leading Japanese CSPs, partner with local vendors and deliver Japan‑driven products
Job Description Systems (80% - 90% is the range of the job responsibility): - Leverage strong technical knowledge of our existing high-side switches portfolio, deep understanding of the technologies, standards and protocols within an industry or end equipment,