QA Sr. Manager, Medical Device

Position Summary

Reporting to the Head of Device Quality Assurance, this role leads quality management operations for medical devices, with a focus on post-market QA, oversight of licensees, and product release for clinical trials. The position also works closely with cross-functional teams across the organization. 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.