Quality Management System (QMS) Specialist
Overview
A global healthcare and diagnostics company is seeking a Quality Management System (QMS) Specialist to support the maintenance and continuous improvement of quality systems related to medical analytical and laboratory testing equipment.
In this role, you will help maintain compliance with international quality standards while collaborating with global teams to ensure alignment across regions. The position plays an important role in supporting quality processes for products distributed in international markets.
Key Responsibilities
Conduct internal audits of the Quality Management System as an internal auditor
Support external audits conducted by regulatory bodies and certification organizations
Communicate and coordinate with global quality teams regarding quality processes and system alignment
Support quality management reviews and internal quality meetings
Contribute to process improvement initiatives, including documentation updates and employee training
Maintain and manage quality records and documentation
Basic Qualifications
Bachelor’s degree or higher (field of study not restricted)
5+ years of experience in quality-related roles
Experience in quality functions within the medical device or pharmaceutical industry
Knowledge of relevant regulatory frameworks, including:
Japan’s Pharmaceutical and Medical Device Act (PMD Act)
Quality System Regulation (QSR)
Other related quality and regulatory standards
Preferred Qualifications
Business-level or intermediate English skills (reading, writing, and basic conversation)
ISO 13485 Lead Auditor certification