[medtech] Quality Operations Staff, Quality Control (sukagawa)

Johnson & Johnson Johnson & Johnson · Pharma · Sukagawa, Fukushima, Japan

Quality Operations Staff, Quality Control role at Johnson & Johnson's MedTech division in Sukagawa, Japan. Responsibilities include managing incoming inspections and processes for active medical devices, overseeing external inspection vendors, coordinating with domestic and international teams, participating in new product introduction projects, and preparing for quality audits. Requires experience in manufacturing, QA/QC, GMP, ISO13485/ISO9001, and strong English communication skills.

What you'd actually do

  1. 社内の多数の製品のうち、能動医療機器(電動医療機器)の受入検査、検査プロセスのマネージメント
  2. 検査委託業者の方の管理監督業務
  3. 関連部門(国内、及び海外ヨーロッパ拠点)との調整、定期的なコール
  4. 新製品導入プロジェクトへの参加、及びプロセスの構築、及び改善
  5. 品質に関する監査（外部・内部）の準備および対応(年複数回)

Skills

Required

  • English proficiency (business level or higher)
  • Basic knowledge of electricity
  • Basic knowledge of Pharmaceutical and Medical Device Act, ISO13485, or ISO9001
  • Ability to investigate and analyze issues and problems, and improve them from a company-wide perspective
  • Basic PC skills (Word, Excel, Outlook, PPT, etc.)

Nice to have

  • Experience in manufacturing, QA/QC, repair, or maintenance
  • Experience in design and development
  • Experience in industries with strict GMP requirements (pharmaceuticals, medical devices, cosmetics) or electrical manufacturing industries (automotive, semiconductors)
  • Broad understanding of supply chain management, quality management, or project management
  • Openness to diverse ideas and a mindset to challenge new things, changes, and modifications
  • High motivation and learning desire, with the ability to apply learned knowledge
  • High communication skills and ability to build good relationships with related departments
  • Logical thinking and continuous efforts to improve operational efficiency

What the JD emphasized

  • GMP
  • ISO13485
  • ISO9001
  • 薬機法
  • 英語力（ビジネスレベル以上必須）