Quality Assurance Senior Specialist ~ Assistant Manager

Confidential Opportunity: Senior Quality System Specialist | Tokyo, Japan

Function: Quality | Sub-Function: Quality Assurance | Category: People Leader

Role Summary

The Senior Quality System Specialist is responsible for overseeing the Quality Management System (QMS), ensuring compliance with Japanese regulations and internal corporate standards. This role provides leadership in maintaining, improving, and implementing quality systems across operations, supporting both internal and external audits, and fostering a culture of quality and compliance.

Key Responsibilities

• Lead and maintain the Quality Management System (QMS) and associated IT systems.

• Manage QMS documentation and records, ensuring accuracy and regulatory compliance.

• Plan, conduct, and respond to internal and external audits, including supplier audits and inspections by health authorities.

• Oversee QMS-related training initiatives for staff.

• Communicate quality-related issues and opportunities to management.

• Ensure adherence to Health, Safety, and Environmental standards within the team.

• Ensure personal and organizational compliance with all applicable regulations, policies, and procedures.

• Perform additional duties as assigned to support quality and compliance objectives.

Experience & Education

• Minimum 3 years of experience in Quality Assurance or Quality Systems in medical devices, pharmaceuticals, or a related field.

• Minimum 2 years of experience as an internal auditor focused on quality management systems.

• Strong knowledge of Japanese medical device regulations, QMS ordinances, and ISO 13485:2016 standards.

• Bachelor’s degree in a relevant scientific or engineering discipline preferred.

Required Knowledge, Skills & Abilities

• Strong analytical and problem-solving skills.

• Basic business-level English proficiency.

• Proficient in Microsoft Office (Excel, Word, PowerPoint) and PDF tools.

• Ability to manage cross-functional collaboration and develop team members.

Preferred Skills

• Compliance Management

• Corrective and Preventive Action (CAPA)

• Internal Controls & Risk Assessments

• Quality Standards & Quality Control (QC)

• Leadership, Inclusive Leadership, and Human-Centered Design

• Process-Oriented & Detail-Oriented