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
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Conduct internal audits of the Quality Management System as an internal auditor
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Support external audits conducted by regulatory bodies and certification organizations
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Communicate and coordinate with global quality teams regarding quality processes and system alignment
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Support quality management reviews and internal quality meetings
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Contribute to process improvement initiatives, including documentation updates and employee training
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Maintain and manage quality records and documentation
Basic Qualifications
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Bachelor’s degree or higher (field of study not restricted)
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5+ years of experience in quality-related roles
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Experience in quality functions within the medical device or pharmaceutical industry
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Knowledge of relevant regulatory frameworks, including:
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Japan’s Pharmaceutical and Medical Device Act (PMD Act)
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Quality System Regulation (QSR)
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Other related quality and regulatory standards
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Preferred Qualifications
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Business-level or intermediate English skills (reading, writing, and basic conversation)
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ISO 13485 Lead Auditor certification