About the role

Aplyr's Quick Take

This role is about leading the development and maintenance of a Quality Management System (QMS) for medical devices, ensuring compliance with ISO standards and local regulations. You'll be coordinating with various departments, managing quality documentation, conducting audits, and reporting to management. It's primarily an individual contributor role with some leadership responsibilities.

Good fit

Ideal candidates have over 5 years of experience in medical device quality management systems and a solid understanding of relevant regulations. Strong problem-solving skills and the ability to communicate effectively in both Japanese and English are essential.

Worth noting

The position offers a hybrid work model, which is a plus for work-life balance. However, the spec is vague on day-to-day responsibilities, so be prepared for some ambiguity in tasks.

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

Aplyr's read

Stryker excels in medical technology, attracting professionals passionate about innovation in orthopedics, surgical, and neurotechnology solutions.
Synthesized from recent postings & public sources

What's promising

•Stryker's innovative products lead advancements in orthopedics and neurotechnology.
•Global presence offers diverse career opportunities across multiple regions.
•Strong focus on research and development fosters continuous innovation.

What to watch

•High competition in the medical technology sector may impact market share.
•Regulatory challenges can affect product launch timelines.
•Complex organizational structure may slow decision-making processes.

Why Stryker

•Stryker's commitment to innovation in medical technology sets it apart.
•Diverse product range across orthopedics, surgical, and neurotechnology.
•Strong emphasis on employee development through varied roles and internships.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Stryker

Stryker

stryker.com

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Stryker is a global leader in medical technology, offering innovative products and services in orthopedics, medical and surgical, and neurotechnology and spine.