QMS Specialist

Position Overview

This role is responsible for maintaining and improving the Quality Management System (QMS) within a regulated healthcare environment. The position ensures compliance with Japanese and international regulations, supports audits, manages nonconformances, and oversees supplier quality activities while driving continuous improvement across the organization.

Key Responsibilities

Quality Management System (QMS)

• Maintain and operate the QMS in compliance with Japanese QMS regulations and applicable international standards

• Ensure quality procedures align with regulatory requirements and internal policies

• Monitor regulatory and industry standard updates and assess business impact

• Conduct gap assessments for new or revised regulations

• Partner with cross-functional teams to implement corrective actions and system updates

• Support management reviews through reporting and performance monitoring

Nonconformance (NCR) Management

• Manage NCR processes to ensure ongoing compliance

• Collect, analyze, and report NCR data for periodic reviews

• Work cross-functionally to prepare review materials

• Identify and propose continuous improvement opportunities within the QMS

Supplier Quality Management

• Execute supplier selection, evaluation, and monitoring in accordance with procedures

• Ensure supplier management processes meet regulatory requirements

• Identify supplier risks and collaborate with stakeholders to mitigate business continuity issues

• Escalate critical quality or compliance issues as required

• Support planning and execution of internal and external audits

• Manage documentation control and training administration

• Perform other related duties as assigned

Qualifications

• 10+ years of experience in medical device quality systems or regulatory compliance, or a relevant bachelor’s degree

• 3–5 years of experience as a Responsible Person for Quality Operations (or equivalent role)

• Strong knowledge of Japanese pharmaceutical and medical device regulations and applicable international standards

• Experience communicating in English with global or cross-regional teams

• Hands-on experience with regulatory submissions and authority interactions

• Proven audit readiness and inspection support experience

• Strong data analysis, reporting, and presentation skills

• Project management and cross-functional collaboration experience

• Ability to stay current with regulatory changes and industry trends

• Capable of managing multiple priorities in a fast-paced environment

• Able to work independently and adapt to changing requirements