QA & Quality Systems Engineer | ISO 9001 | Singapore

Peptide Atlas; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

GenScript Singapore is seeking a QA Engineer to support the QA Manager in building and maintaining the Quality Management System (QMS) and ensuring compliance with internal standards and regulatory requirements. The role involves CAPA management, audits, document control, change management, risk assessment, data analysis, and training.

Onsite in Singapore, you will work across QA functions to drive continuous improvement and maintain product quality and regulatory readiness.

Qualifications

• Experience with CAPA, FMEA, Root Cause Analysis and Statistical Process Control (SPC).
• Familiarity with document control and change management systems.
• Fluent in English; Mandarin Chinese is an advantage for cross‑regional collaboration.

Responsibilities

• Develop, implement and maintain the site QMS aligned with ISO 9001:2015 and applicable standards.
• Lead CAPA processes, investigations, and verify effectiveness.
• Perform internal and supplier audits, support regulatory inspections and routine on-site quality inspections.
• Review, approve and maintain controlled documents (SOPs, forms, test plans, validation reports).
• Support Engineering Change Orders and Document Change Controls.
• Participate in risk assessments and FMEA; implement mitigation strategies.
• Monitor CAPAs, training completions, NCM handling, and other QMS metrics.
• Analyze quality data to identify systemic issues and drive continuous improvement projects.
• Investigate customer complaints and non-conforming materials; implement corrective actions.
• Develop and deliver quality training for new hires and current staff.
• Perform ad hoc assignments as required by QA Manager.

Skills

CAPA

FMEA

Root Cause Analysis

Statistical Process Control

Document Control

Change Management

Quality Audits

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Biomedical Sciences

Bachelor’s degree in Life Sciences

Tools

Quality tools

Job description

GenScript Singapore is seeking a QA Engineer to support the QA Manager in building and maintaining the Quality Management System (QMS) and ensuring compliance with internal standards and regulatory requirements. The role involves CAPA management, audits, document control, change management, risk assessment, data analysis, and training.

Onsite in Singapore, you will work across QA functions to drive continuous improvement and maintain product quality and regulatory readiness.