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Job Description:

Quality & Regulatory Compliance in Johnson and Johnson K.K. is recruiting for Surgery QRC Staff, located in Tokyo HQ office.

Key Responsibilities

Ensure compliance with applicable domestic and international regulations, standards, and quality requirements. Develop and maintain an effective Quality Management System (QMS) that addresses the needs of internal stakeholders, and execute quality system activities in accordance with established procedures, including document control, change management, and business license management.

In addition, develop and implement initiatives that deliver value to both internal stakeholders and customers through the QMS. Proactively identify and understand customer needs, business requirements, and organizational changes, while building strong and trusted relationships with stakeholders, including global partners, to establish simpler, more efficient, and reliable QMS processes.

Experience and Skills:

Required:

• Knowledge and practical experience of laws and QMS ministerial requirements
• Proactive approach/ Able to appropriately demonstrate unique initiatives
• Ability to work both independently and in collaboration with others.
• Proactive approach/uses own initiative appropriately.
• Logical thinking, decision making, problem-solving skills, positive thinking, and attitude to learn new things.
• Has a strong commitment to achieving goals and a flexible ability to execute.
• Native verbal and written communication skills in Japanese.

Preferred:

• At least 3 years of experience in Quality Assurance or Quality System function within the regulated Medical Device or Pharmaceutical industry
• English skill in business level.
• Experience in global/cross culture environment.
• IT/Digital literacy

Education:

•     Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).

 

Johnson and Johnson K.K.のMedTech, Quality Assurance部門におけるQuality &　Regulatory Compliance Surgery QRCスタッフを募集します。
 

​経験とスキル：

必須：

• 法令及びQMS省令の要求事項の知識と実践経験
• プロアクティブなアプローチ/独自のイニシアチブを適切に発揮できる
• 論理的思考、意思決定、問題解決スキル、ポジティブ思考、新しいことを学ぶ姿勢
• 目標達成に対する強いコミットメント及び柔軟性のある実行力
• 日本語での口頭および文書による優れたコミュニケーション能力

Preferred:

• 3 年以上の医療機器又は医薬品業界における品質保証又品質マネジメントシステムの構築・維持・管理に関連する業務経験
• ビジネスレベルの英語力
• クロスカルチャー/グローバル環境での経験
• IT/デジタルリテラシー

Education:

• 大学卒業 (大学卒業以上またはそれと同等の資格を有する者）

Required Skills:

Preferred Skills: