Quality Systems Lead - ISO & Process Excellence

Sysmex Group; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Sysmex Group seeks a QM Senior Specialist to ensure effective implementation of QMS processes including Document Control, Change Control, Complaint Management and FSCA/FCA for Non-SCORP products. You will drive SAP-based improvements across Affiliates regionally and support the Quality Manager in Quality Operations, overseeing Process FMEAs for ISO compliance.

You will serve as primary Document Controller, manage audits, CAPA, and cross-functional change activities, while supporting complaint

Qualifications

• Relevant Diploma / Degree in a scientific or engineering discipline.
• Minimum 5 years of experience in a Quality Assurance role within the Healthcare industry.
• Certified Lead Auditor for ISO 13485 and/or ISO 9001.
• Knowledge and experience in ISO 14001 internal audits and Workplace Safety and Health requirements.
• ISO 13485 / ISO 9001 Quality Management Systems (QMS).
• ISO 14001 Environmental Management System (EMS).
• ISO 27001 Information Security Management System (ISMS).
• Workplace Safety and Health Act.
• Microsoft Office applications.
• Experience with Complaint Handling systems (e.g. TrackWise) is an advantage.
• Knowledge of Computer System Validation (CSV) and understanding of 21 CFR Part 11, Part 210 and Part 820 will be beneficial.
• Responsible and self-motivated.
• Strong team player.
• Keen to learn and continuously improve.
• Good communication and interpersonal skills.
• Experience in the In-vitro Diagnostics (IVD) industry is preferred but not essential.
• Approximately 10% travel.

Responsibilities

• Assist in maintaining and monitoring the Quality Management System (QMS) to align with ISO 13485 / ISO 9001 and other standards.
• Support internal audits and external audits to Affiliates and Partners.
• Prepare Management Review inputs and support CAPA processes with timely investigations and closures.
• Manage document control and change control processes to ensure version control and traceability.
• Lead or support Change Control activities with cross-functional stakeholders and ensure timely communication.
• Monitor and manage customer complaints via the GES/TrackWise system and escalate as needed.
• Provide QA support to Production and QC teams and lead RCA activities for quality issues.

Skills

Quality Assurance

Auditing

Communication

Teamwork

Problem Solving

Education

Diploma/ Degree in science or engineering

Lead Auditor ISO 13485/9001

ISO 14001 Internal Audits knowledge

Tools

TrackWise

MS Office

Job description

Sysmex Group seeks a QM Senior Specialist to ensure effective implementation of QMS processes including Document Control, Change Control, Complaint Management and FSCA/FCA for Non-SCORP products. You will drive SAP-based improvements across Affiliates regionally and support the Quality Manager in Quality Operations, overseeing Process FMEAs for ISO compliance.

You will serve as primary Document Controller, manage audits, CAPA, and cross-functional change activities, while supporting complaint