QMS Engineer (ISO13485)

About the role

Our client, a leading contract manufacturing MNC, is seeking a QMS Engineer to support the implementation and maintenance of its Quality Management System in line with ISO 13485. The role will be based in the North of Singapore and will contribute to ongoing transformation projects within the quality team.

Key responsibilities

• Support implementation and maintenance of the QMS according to ISO 13485 and regulatory requirements.
• Manage controlled documentation such as procedures, work instructions, specifications, and technical records.
• Plan, coordinate and conduct internal audits to ensure compliance and audit readiness.
• Maintain and improve QMS processes including document control, change management and system validation.
• Review and update quality documentation to align with operational and regulatory standards.
• Prepare reports, maintain quality records and support management review activities.
• Identify process improvement opportunities and drive corrective and preventive actions.
• Deliver quality‑related training and communicate updates on quality and regulatory requirements.
• Support customer audits, external assessments and quality‑related inquiries.
• Assist in deploying QMS frameworks for new operations or facilities.

Required profile

• Minimum Diploma in a relevant discipline.
• 2‑3 years of experience in quality management systems within a manufacturing environment.
• Hands‑on experience with ISO 13485.

Required skills

• ISO 13485 knowledge.
• Quality Management System (QMS) implementation.
• Internal auditing.
• Document control.
• Change management.
• System validation.