QA Sr. Manager, Medical Device

Key Roles and Responsibilities

• Oversee post-market quality activities such as complaint trend monitoring, risk file maintenance, and product/parts inspections.
  

• Analyze data using statistical methods to identify trends, issues, and improvement opportunities.
  

• Prepare, review, and maintain documentation required for the device quality management system.
  

• Manage and assess suppliers in Japan and overseas, collaborating with them on quality-related issues.
  

• Partner with global teams on complaint handling, non conformance, CAPA, change control, and supplier evaluations.
  

• Stay current on regulations, standards, and guidance related to medical device quality systems.
  

Requirements

Desired Education, Skills & Experience

• 3+ years’ experience in the medical device industry
  

• Understanding of the PMD Act and related Japanese regulations.
  

• Strong knowledge of ISO 13485; familiarity with FDA 21 CFR 820 is a plus.
  

• Experience in QMS operations, including CAPA, non conformance, complaint handling, product release/recall, audits, and inspections.
  

• Practical experience with medical device risk management (e.g., ISO 14971).
  

• Hands-on use of statistical tools for data analysis, sampling, and process improvement.
  

• Strong Japanese communication skills; English communication skills preferred.