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
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
Job Description: Business Overview Rakuten Group provides more than 70 services in a wide range of fields, including e-commerce, travel, digital content, and other Internet services in Japan and overseas, as well as financial services such
Title: Senior Quality Specialist Location: Japan HQ - About the job As Senior Quality Specialist (Expert Japan) within our Vaccine R&D Quality Operations team, youll lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global quality standards while
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
The Quality & Training Specialist (QTS) department ensures that safety policies are enforced accurately and consistently at scale. The Q&T Market Lead acts as the strategic bridge between high-level policy and boots-on-the-ground execution. While Specialists focus on quality assurance, the
Kō wai mātou? Who are we? Zespri is more than simply the worlds single-largest marketer of kiwifruit. We like to think of ourselves as fruit on a mission and as rebels with a cause: to help
The Quality & Training Specialist (QTS) department ensures that safety policies are enforced accurately and consistently at scale. The Q&T Market Lead acts as the strategic bridge between high-level policy and boots-on-the-ground execution. While Specialists focus on quality assurance, the
Overview: We are looking for a Movie and TV data/metadata Specialist to join our Japanese team. You will be working with a leading consumer technology company as a contributor to the finished products released in the Japanese
Req ID 88746 | Miyoshi, Japan, ZF Japan Co., Ltd. About the Team: Our Supply Chain and Production Control team manages end-to-end supply chain operations, from demand planning to material procurement, logistics coordination, and inventory optimization.
About Klook We are a leading pan-regional experiences platform in Asia Pacific, purpose built to digitalize experiences and make them accessible to every traveler. Our mission is to build the digital infrastructure for the global experience
Job Description: Business Overview The Ad & Media Company is committed to the overall development of the Rakuten Group, aiming to make Advertising the fourth pillar of the group, following EC, FinTech, and Mobile. Within the
Site Support Specialist UMGC Asia Location: Camp Kinser, Futenma, Camp Courtney, Okinawa Contingent III, 75%-Time, Grade 002 University of Maryland Global Campus (UMGC) Asia seeks a Southern Sites Site Support Specialist, serving primarily Camp Kinser, Futenma, and Camp
The Solution Sales Sr Specialist is a strategic professional who stays abreast of developments within own field and contributes to directional strategy by considering their application in own job and the business. Recognized technical authority for an
Overview Waters Corporation is currently looking for a Senior Talent Acquisition Specialist to support our key recruitment activities in Japan. This person will play a critical role in supporting managers across the organisation in the recruitment of
클래식 음악 콘텐츠 전문가 모집 안내 업무 내용 본 프로젝트는 클라이언트 사의 음악 콘텐츠의 품질 관리 및 큐레이팅을 담당하게 되는 프로젝트입니다. 클래식 음악에 중점을 두고 일련의 디지털 음악 산업 지침 표준을 기반으로 콘텐츠를 검토하는 작업을 주로
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a
We are looking for AI Data Specialists to support the improvement of AI-generated content in Japanese. Job Type: Freelance Location: Work from home Work Schedule: Part-time - 10+ hours per week. Flexible - work whenever you want.
POSITION SUMMARY Install, configure, manage, maintain, test, evaluate, and repair computer networks, workstations, support server system(s), supporting hardware/software, user accounts, and computer/telephone rooms. Train/instruct users in proper use and security of all systems. Troubleshoot/repair/resolve technical problems/issues