[quality] 品質保証部 品質保証 スタッフ (surgery)

Johnson & Johnson Johnson & Johnson · Pharma · Chiyoda, Tokyo, Japan

This role is in Quality Assurance within the medical device sector, focusing on ensuring product quality, compliance with regulations, and managing customer feedback and complaints. It involves establishing quality assurance methods, responding to product defects, and supporting new technology deployment. The role requires understanding legal and company policies, identifying risks, and contributing to new product introductions and supply chain management.

What you'd actually do

  1. 保健衛生上の危害の発生及び拡大の防止、コンプライアンスリスクの最小化。
  2. 海外製造業者の製造所が日本の法的要求を満たすための指導・監督（製造所認定又は登録業務、海外事業所のQMS適合性など）
  3. 製品の設計管理、量産移管、製造・品質管理の各プロセスの把握及び各プロセスからの製品の品質保証方法の確立
  4. 製品の市場への出荷に係る体制構築、逸脱、不適合発生時の出荷可否承認、出荷停止/出荷停止解除の指示
  5. 顧客フィードバック（含 苦情）プロセスの管理、苦情処理業務の遂行

Skills

Required

  • Quality Assurance
  • Regulatory Compliance
  • Risk Management
  • Supply Chain Management
  • Customer Complaint Handling
  • Product Lifecycle Management
  • Documentation Control

Nice to have

  • Medical Device Regulations
  • QMS (Quality Management System)
  • CAPA (Corrective and Preventive Actions)
  • Auditing

What the JD emphasized

  • 日本の法的要求