Quality Management Specialist: Complaint & Post-Market (Medical Devices)

Sysmex Group; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Sysmex Asia Pacific Pte Ltd in Singapore seeks a Quality Management (QM) Specialist to ensure regulatory compliance for the organization, including Complaint Management and Post Market Activities related to Robotic Assisted Surgery (RAS) and SAP Quality Performance. The role ensures accuracy and continuous improvement across quality processes.

You will manage Environmental data in ECO Track, monitor regulations, and support regional quality initiatives while coordinating with multiple affiliates

Qualifications

• Minimum 2 years' QA experience in the Medical Devices industry.
• Must hold Certified Internal Auditor for ISO 13485/9001 and/or ISO 14001.
• Knowledge of ISO 13485, ISO 9001, ISO 27001, ISO 14001, and WSH.
• Proficient in MS Office and data analysis.

Responsibilities

• Oversee Complaint Management and investigation closure.
• Manage Post Market Activities and FCA coordination.
• Support risk management by tracking QA risks and mitigations.
• Monitor Quality and Environmental Objectives and report KPIs.
• Provide guidance on EMS and ESG regulatory requirements.

Skills

Data trending and analysis

Problem solving

Cross-functional coordination

Regulatory compliance

Education

Certified Internal Auditor ISO 13485/9001/14001

Tools

Microsoft Office

SharePoint

Job description

Sysmex Asia Pacific Pte Ltd in Singapore seeks a Quality Management (QM) Specialist to ensure regulatory compliance for the organization, including Complaint Management and Post Market Activities related to Robotic Assisted Surgery (RAS) and SAP Quality Performance. The role ensures accuracy and continuous improvement across quality processes.

You will manage Environmental data in ECO Track, monitor regulations, and support regional quality initiatives while coordinating with multiple affiliates