Quality Management Specialist – Medical Devices

SYSMEX ASIA PACIFIC PTE. LTD.; Singapore; Presencial; SGD 70.000 - 110.000; Jornada completa

Descripción de la vacante

SYSMEX ASIA PACIFIC PTE. LTD. is seeking a Quality Management (QM) Specialist to ensure regulatory and quality standards are met across complaint management, post-market activities, and SAP Quality Performance.

The role supports regional quality processes and environmental data coordination. Responsibilities include managing complaint investigations, FCA coordination, data analysis, and monthly regional quality meetings.

Formación

• Minimum 2 years' experience in a Quality Assurance role within the Medical Devices industry.
• Certified Internal Auditor for ISO 13485 / ISO 9001 and/or ISO 14001.
• Knowledge of ISO 13485, ISO 9001, ISO 27001, ISO 14001 and WSH.
• Proficient in Microsoft Office and data analysis.

Responsabilidades

• Apply systematic problem-solving to identify, prioritize, communicate, and resolve product quality issues.
• Track and monitor customer complaints with Legal Manufacturer or outsourced service providers for investigation and closure.
• Manage complaint logs in SharePoint to ensure timely updates on progress.
• Coordinate with CSR for defective units availability and with Regulatory Affairs on event reportability.

Conocimientos

Quality Assurance

Data Analysis

Problem Solving

Microsoft Office

Documentation

Educación

ISO 13485 Internal Auditor

ISO 9001 Internal Auditor

ISO 14001 Internal Auditor

WSH Compliance

Herramientas

SharePoint

ECO Track

QMS

EMS/ESG systems

Descripción del empleo

SYSMEX ASIA PACIFIC PTE. LTD. is seeking a Quality Management (QM) Specialist to ensure regulatory and quality standards are met across complaint management, post-market activities, and SAP Quality Performance.

The role supports regional quality processes and environmental data coordination. Responsibilities include managing complaint investigations, FCA coordination, data analysis, and monthly regional quality meetings.