Head of Design Quality

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募集要項

会社概要

同社は、医療・情報通信分野などに向けて製品やソリューションを提供するグローバルテクノロジー企業です。高度な技術力を活かし、幅広い業界の顧客を支援しています。研究開発を通じて新たな価値創出や技術革新に取り組んでいます。人々の生活や社会の発展に貢献する事業を展開しています。

業務内容

This leadership position is responsible for overseeing Design Quality within a research and development organization, ensuring that new products are developed in compliance with quality, safety, and regulatory requirements. Working closely with R&D, manufacturing, and global quality teams, the role provides an opportunity to shape development quality strategy across the entire product lifecycle within a global healthcare technology environment.
Main responsibilities:

• Lead the Design Quality function within the R&D organization.
• Develop quality strategies for New Product Development (NPD) projects.
• Drive Design Control processes.
• Participate in development reviews.
• Lead quality assurance activities throughout the product lifecycle.
• Provide quality-related guidance and support to development teams.
• Design Assurance / Risk Management
  • Lead risk management activities in accordance with ISO 14971.
  • Conduct risk analyses, including FMEA.
  • Review Verification & Validation activities.
  • Manage Design Transfer processes.
  • Promote product quality and safety evaluations.
• QMS Management
  • Maintain and improve the Quality Management System within the development organization.
  • Ensure compliance with ISO 13485.
  • Manage SOPs and procedural documentation.
  • Drive CAPA and change management activities.
  • Monitor quality performance metrics.
• Regulatory & Audit Support
  • Support FDA inspections and audits.
  • Support ISO audits.
  • Support global quality audits.
  • Drive corrective and continuous improvement activities.
• People & Organization Leadership
  • Manage the Design Quality organization.
  • Develop and mentor team members.
  • Collaborate with global quality organizations.
  • Manage key stakeholder relationships across functions.

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応募条件

Minimum requirements:

• Quality Assurance experience within medical devices, pharmaceuticals, or other regulated industries
• Experience in New Product Development and/or Design Quality
• Knowledge and hands-on experience with Design Control
• Knowledge of ISO 13485 and ISO 14971
• Advanced English proficiency
  • TOEIC score of 800 or above, Business-level English communication skills

Preferred qualifications:

• FDA audit experience
• Design Assurance experience
• Medical Device New Product Development (NPD) experience
• Management experience within a global organization
• Experience in Quality Systems development and improvement

給与

1500 - 1800 万円

勤務地

東京