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
【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
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com and careers.stryker.com.
Facts:
● 2024 Sales: $22.6 billion
● Industry: Medical Instruments & Supplies
● Employees: 53,000 worldwide
● 40 years of sales growth leading up to 2020
● 44+ Manufacturing and R&D Locations Worldwide
● $1.5 billion spent on research and development in 2024
● ~14,200 patents owned globally in 2024
● Products sold in ~75 countries
● Fortune 500 Company
● 7 consecutive years as one of Fortune's World's Best Workplaces
Stryker’s social media community guidelines: https://www.stryker.com/content/m/legal/social-media-community-guidelines/en/index.html
Notice Regarding Employee Conduct on Facebook/LinkedIn
Meta/LinkedIn does not permit employers to verify or validate “employees” in the (META: “Works at” LinkedIn: “Experience”) section of users’ profiles. Please be aware that the views expressed by individuals on their personal accounts and do not necessarily represent the views of our company. If you encounter any issues with a person claiming to be our employee, we recommend using the “Report Profile” feature. If you’d like to report concerns to our Ethics Hotline, you may do so at: https://app.convercent.com/en-us/LandingPage/b6bb4e84-9fcb-ea11-a974-000d3ab9f296
