Manager Quality Assurance
Core
Establish, maintain, and improve Quality Management Systems (QMS) and oversee quality operations for medical devices in Japan, ensuring compliance with local regulations and global standards.
Role type
Manager, Quality Assurance (Medical Devices)
Builds
Medical device products (Continuous Glucose Monitoring systems) for the Japanese market
Domain
Medical Devices / Healthcare Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Japanese regulatory compliance (J-PMD Act, QMS Ordinance, GVP), QMS establishment and maintenance, CAPA management, audit management, supplier quality management, risk management, product release and inspection oversight, field action and recall management, cross-functional leadership
Preferred skills
Advanced degree in Life Sciences, Engineering, or Pharmacy, experience in pharmaceutical industry, deep understanding of product lifecycle quality
Technologies
None explicitly listed
Responsibilities
Lead QMS planning and change management for regulatory requirements; manage internal and external audits; oversee manufacturing quality activities including incoming checks and product release; manage supplier and subcontractor quality; handle nonconformance, rework, and field actions/recalls; create Device Master Records and review Design History Records; monitor processes and drive continuous improvement
Seniority
Manager, hands-on leadership