Job Description

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 -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MilestoneFormal Design Review各種ReviewOperation Mechanism等においてGlobal MemberとのReviewDiscussionFacilitation

• 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 Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience).
• For roles in USA - Bachelors 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

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