Head of Design Quality

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Job details

Company overview

The company is a global technology company serving diverse industries. It supports customers across a wide range of sectors through advanced technological expertise. It drives innovation and value creation through continuous research and development. It contributes to improving people's lives and advancing society through its business activities.

Responsibilities

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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Requirements

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

Salary

15 - 18 million yen

Location

Tokyo