シニアQAスペシャリスト/ Sr QA Specialist

An international healthcare and medical device company is looking for a Sr. QA Specialist for its diabetes care business. The selected candidate will lead quality assurance and product safety processes, ensure regulatory compliance, manage safety reporting activities, and collaborate with local and global stakeholders to support medical device and IVD operations.

Responsibilities:

• Lead Medical Device and IVD product safety processes in compliance with legal requirements and company policies
• Collaborate with the Domestic Quality Assurance Manager and other QA departments to support ADC Japan operations
• Establish and drive safety strategies aligned with global quality initiatives and business objectives
• Ensure consistent application of safety processes, SOPs, and locally developed procedures
• Adapt global policies to meet local regulatory requirements and market needs
• Evaluate customer feedback and complaints and report safety events to relevant authorities
• Escalate significant product safety issues with sufficient details for investigation and corrective actions
• Coordinate with local, area, and global subject matter experts to close safety reports
• Plan and execute field actions and field corrective actions when necessary
• Develop and maintain product safety status reports and key issue resolution updates
• Escalate significant issues to the Head of Quality and the MAH Director when applicable
• Build effective relationships with local regulators and agencies, including MHLW and PMDA
• Provide support for QS, QA, and QC activities as needed
• Develop procedures and policies to ensure compliance and resolve identified issues
• Lead and participate in cross-functional teams addressing Medical Device and IVD safety issues

Requirements:

• More than 5 years of experience in QA, GVP, or PV roles within the medical device, pharmaceutical, or related industry
• Experience working in global cross-functional environments
• Experience leading and participating in cross-functional teams for product safety issue resolution
• Strong knowledge of GVP Ordinance, PMD Act, and related Administrative Notifications for Medical Device and IVD product safety
• Knowledge of local regulatory requirements, including MHLW and PMDA regulations
• Native level Japanese; fluent level English

Preferred requirements:

• Knowledge of ISO 13485, 21CFR Part 820, and ISO14971
• QA experience in Medical Device
• Familiarity with ISO 9000/13485 and QSR regulations
• Experience in change management
• Experience working within matrix organisations
• Program and project management experience
• Cross-functional and cross-divisional experience
• Applicable technical knowledge and experience

About the Company:

This company is a global healthcare organisation specialising in medical devices and diabetes care solutions. It is recognised internationally for its advanced healthcare technologies and commitment to quality and regulatory excellence.

Keywords:

品質保証, 医療機器, 体外診断用医薬品, 安全管理, 薬事, 品質管理, プロジェクトマネジメント, クロスファンクショナル, 医療業界, QAスペシャリスト, 是正措置, コンプライアンス, 求人, 外資系

Job Ref: VJ24UV