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The Specialist, Quality Management position at SYSMEX ASIA PACIFIC PTE. LTD. involves overseeing quality systems related to Complaint Management and Post Market Activities for Robotic Assisted Surgery products. The role requires a minimum of two years of experience in Quality Assurance within the medical devices industry, along with relevant certifications.
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Job Summary
The role ensures organizational adherence to regulatory and quality standards by managing critical systems for Robotic Assisted Surgery business.
Responsibilities include systematic problem-solving for product quality issues, coordinating complaint investigations, and managing post-market corrective actions.
The specialist supports environmental compliance, monitors quality objectives, and facilitates regional quality meetings to ensure consistent practices across affiliates.
Matching Summary
Match Score: 75
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The Specialist, Quality Management position at SYSMEX ASIA PACIFIC PTE. LTD. involves overseeing quality systems related to Complaint Management and Post Market Activities for Robotic Assisted Surgery products. The role requires a minimum of two years of experience in Quality Assurance within the medical devices industry, along with relevant certifications.
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Skills & Requirements
Must-have
Complaint Management in Medical Devices
Post-Market Activities and Vigilance Reporting
ISO 13485 Quality Management Systems
Environmental Management Systems (EMS)
Risk Management and Enterprise Risk Register
Internal and External Audit Support
Data Trending and Analysis
Nice-to-have
Regional Quality Meeting Coordination
Continuous Improvement Methodologies
Cross-functional Stakeholder Collaboration
SAP Quality Performance Monitoring
Workplace Safety and Health Regulations
Key Requirements
Minimum 2 years experience in Quality Assurance
Experience in Medical Devices industry
Certified Internal Auditor for ISO13485 / ISO9001 / ISO14001