**Job Description Summary** 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). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. **Job Description** **Roles and Responsibilities** **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。** **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** **GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.** + Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. + A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. + Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. + Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. **Required Qualifications** + For roles outside of the USA- This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience). + For roles in USA - Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)). **Desired Characteristics** + Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.Note: **To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA.** **For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.** **Additional Information** **Relocation Assistance Provided:** No