シニア品質保証アナリスト/ Sr Quality Assurance Analyst

A global medical device company is hiring a Senior Quality Assurance Analyst. The selected candidate will lead QMS and quality operations in compliance with Japanese regulatory requirements.

Responsibilities:

• Oversee QMS operations in line with JP-MD Act, QMS, and GVP ordinances
• Manage document control, training, internal audits, and CAPA with HQ teams
• Lead supplier management, including contracts and regulatory license oversight
• Support domestic and overseas manufacturing from a quality/regulatory standpoint
• Coordinate product realisation, risk management, and market feedback handling
• Facilitate field actions including product returns, documentation, and reporting

Requirements:

• More than 5 years of experience in quality and QMS and QC activities in medical device/IVD industry
• Experience of QMS establishment is ideal
• Prior experience in internal auditor, and external auditor
• Proven experience in communicating with Japanese regulatory authorities (audit response)
• Native level written and spoken Japanese; business level English

About the Company:

A leading global medical device company dedicated to improving healthcare through innovative technology. The company develops advanced, user-friendly devices that deliver real-time glucose insights, helping individuals make informed health decisions. With a strong focus on innovation, accuracy, and connectivity, it enhances the quality of life for people managing diabetes globally.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: MZ1OYH