Specialist, Quality Management

Sysmex Group; Singapore; On-site; SGD 48,000 - 78,000; Full time

Job summary

Sysmex Group in Singapore is seeking a Quality Assurance professional to support and maintain ISO 13485 and ISO 9001, ensuring regulatory compliance and driving quality improvements across the organization.

The role will conduct internal, supplier, and external quality audits, manage complaints and CAPAs, coordinate change control, recalls, and field actions, and support ISO 14001 environmental and workplace safety compliance, while maintaining documentation and SOPs.

Qualifications

• Diploma or degree in a scientific or engineering field.
• Quality Assurance/Quality Management experience in regulated industries.
• Knowledge of ISO 13485 and ISO 9001.
• Lead Auditor certification is an advantage.
• Experience with complaint handling systems and CSV is preferred.
• Strong communication and organizational skills.

Responsibilities

• Maintain and improve Quality Management Systems (ISO 13485 & ISO 9001).
• Conduct internal, supplier, and external quality audits.
• Manage quality complaints, CAPAs, and post-market surveillance activities.
• Coordinate change control, recalls, and field corrective actions.
• Support ISO 14001 Environmental Management System and Workplace Safety & Health compliance.
• Maintain quality documentation, SOPs, and document control processes.

Skills

QA/QM experience

ISO 13485 knowledge

ISO 9001 knowledge

Lead Auditor certification

TrackWise

CSV knowledge

Communication

Organizational skills

Problem solving

Education

Diploma/Degree in a relevant scientific or engineering discipline

Tools

TrackWise

Job description

Key Purpose

Support and maintain Quality Management, Environmental Management, and Workplace Safety & Health systems to ensure compliance with regulatory and ISO requirements, while driving quality improvement initiatives across the organization.

Key Responsibilities

• Maintain and improve Quality Management Systems (ISO 13485 & ISO 9001).


• Conduct internal, supplier, and external quality audits.


• Manage quality complaints, CAPAs, and post-market surveillance activities.


• Coordinate change control, recalls, and field corrective actions.


• Support ISO 14001 Environmental Management System and Workplace Safety & Health compliance.


• Maintain quality documentation, SOPs, and document control processes.

Requirements

• Diploma/Degree in a relevant scientific or engineering discipline.


• At least 2 years of Quality Assurance/Quality Management experience in healthcare, medical device, IVD, pharmaceutical, or other regulated industries.


• Knowledge of ISO 13485, ISO 9001, and quality management systems.


• Certified ISO Lead Auditor is an advantage.


• Experience in complaint handling systems (e.g. TrackWise) and CSV is preferred.


• Strong communication, organizational, and problem-solving skills.