Quality Engineer
GE HealthCare · Hino
Job Description Summary
品質保証本部のメンバーとして、日野工場で設計・製造される医療機器を世界中のお客様に届けるため、米国FDAや欧州MDRをはじめとする各国の医療機器規制、ならびにGEHC社内のQuality Management Systemに準拠した設計・製造活動を確実なものとし、日野内のみならず海外の開発拠点や協力工場のメンバーとも積極的・能動的に協力し、各国規制当局・認証機関等による査察・監査に対応し、製品の安全性と法規制遵守を推進する役割を担っていただきます。１名のメンバーを募集します。Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and Responsibilities
- 各国の医療機器規制要求、ならびに社内のQuality Management Systemを理解し、日野工場での設計・製造活動への展開・指導。
- それら変更に対する理解・展開・指導。
- 品質方針の展開・指導。
- 製品開発、生産移管、製造変更管理等でのQMS活動（Milestone、Formal Design Review、各種Review、Operation Mechanism等）において、Global MemberとのReview、Discussion、Facilitation。
- 各国規制当局・認証機関による外部査察・監査への対応。
- 内部監査プラン立案・実施。社内Global memberによる内部監査への対応。
- 不適合発生時における不適合処置・是正処置・予防処置のLeadとFacilitation
Required Qualifications
- Quality Management Systemを推進するリーダー役としての実務経験。
- もしくは、技術における設計・開発・Project Managementなどの経験・知識を通したDesign Controlへの理解。
- または、製造におけるTeam Management・Production Supportなどの経験・知識を通したProduction & Process Controlへの理解。
- 海外拠点のメンバーとLogicalかつ能動的にCommunicationを取ることが出来る能力と、海外からの査察・監査に対し積極的に前面に立って対応することが出来る能力。
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Additional Information
Relocation Assistance Provided: No
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