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 InformationRelocation Assistance Provided: No
Skills Required
- Practical experience in leading Quality Management Systems implementation
- Understanding of Design Control through design, development, or Project Management experience
- Understanding of Production & Process Control through Team Management or Production Support experience
- Ability to communicate logically and proactively with international teams
GE Healthcare Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.
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Healthcare Strength — Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
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Retirement Support — Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
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Strong & Reliable Incentives — Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.
GE Healthcare Insights
What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.
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