ISO13485 QMS Engineer — Quality & Compliance Leader

RecruitPedia Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

RecruitPedia Pte Ltd is recruiting a QMS Engineer for a leading manufacturing MNC in the Singapore North region. The role focuses on implementing and maintaining the QMS in line with ISO 13485 and regulatory requirements, ensuring controlled, up-to-date documentation.

The successful candidate will conduct internal audits, drive CAPA and change management, deliver training, and assist with customer audits and new operations deployments to sustain compliance and continuous improvement.

Qualifications

• Diploma in a relevant discipline.
• 2-3 years of quality management experience in manufacturing.
• Experience with ISO 13485 is required.

Responsibilities

• Support the implementation and maintenance of the QMS per ISO 13485 and regulatory requirements.
• Plan, coordinate and conduct internal audits to ensure audit readiness.
• Maintain and improve QMS processes including document control and change management.
• Review and update quality documentation to align with standards and operations.
• Prepare reports and support management review activities.
• Identify improvement opportunities and drive CAPA.

Skills

QMS implementation

Internal audits

Documentation control

Regulatory compliance

Education

Diploma in relevant discipline

Job description

RecruitPedia Pte Ltd is recruiting a QMS Engineer for a leading manufacturing MNC in the Singapore North region. The role focuses on implementing and maintaining the QMS in line with ISO 13485 and regulatory requirements, ensuring controlled, up-to-date documentation.

The successful candidate will conduct internal audits, drive CAPA and change management, deliver training, and assist with customer audits and new operations deployments to sustain compliance and continuous improvement.