デバイス品質保証マネージャー/ Device Quality Assurance, Manager

A global biotechnology company is looking for a Device Quality Assurance Manager. The selected candidate will oversee and improve device quality systems, supplier management, and compliance activities.

Responsibilities:

• Develop and maintain documentation for the device quality management system
• Oversee supplier evaluation and quality issue resolution for domestic and international vendors
• Lead or support internal and external audits, including preparation and follow-up
• Coordinate with global teams on complaints, nonconformance, CAPA, and change control
• Ensure regulatory and quality standard compliance across device operations
• Stay up to date with relevant medical device quality regulations and guidance

Requirements:

• Bachelor’s degree or above in science engineering, or a relevant domain
• More than 3 years of experience in medical device industry
• Experience in quality assurance operations (quality management system, CAPA, nonconformance, feedback and complaint handling, and external and internal audits, etc.)
• Prior experience with the risk-based approach (ISO 14971) is preferred
• Knowledge of PMD Act, relevant regulations and guidelines in Japan
• Familiarity with ISO 13485 and MHLW MO 169
• Understanding of FDA 21 CFR Part 820 is ideal
• Proficient in reading, written, and verbal English is ideal

About the Company:

A biotechnology company, the organisation develops highly specialised, top-quality treatments targeting very serious illnesses.

Keywords:

バイオテクノロジー, 品質保証, 医療機器, 求人, 外資系

Job Ref: IB4POQ