Quality Management System Engineer (ISO13485) - RPAL

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 45,000 - 65,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. invites applications for a QMS Engineer to join the Quality team driving ongoing transformation projects in a Manufacturing MNC.

The role focuses on implementing and maintaining QMS per ISO 13485, managing controlled documentation, and coordinating internal audits to ensure regulatory readiness. The successful candidate will have a Diploma in a relevant discipline and 2–3 years of quality management experience in manufacturing, with hands-on ISO 13485 exposure and a

Qualifications

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

Responsibilities

• Support the implementation and maintenance of the QMS per ISO 13485 and regulatory requirements.
• Manage controlled documentation including procedures, work instructions and specs.
• 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 standards.
• Prepare reports, maintain quality records and support management review activities.
• Identify process improvement opportunities and drive CAPA actions.
• Deliver quality training and communicate updates on quality and regulatory requirements.
• Support customer audits, external assessments and quality inquiries.
• Assist deployment of QMS frameworks for new operations or facilities.
• Participate in internal audits and support continuous compliance initiatives.

Skills

Quality management

Audit readiness

Education

Diploma in relevant discipline

Job description

Our client is a Manufacturing MNC, one of the leading players in the Contract Manufacturing sector. Due to business needs, they are now recruiting a QMS Engineer to be part of their Quality team for ongoing transformation projects. They are located in the North – easily accessible.

Duties of QMS Engineer

• Support the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements.
• Manage controlled documentation, including 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 activities.
• Review and update quality documentation to ensure alignment 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 the deployment of QMS frameworks for new operations or facilities.
• Participate in internal auditing activities and support continuous compliance initiatives.

Requirements

• Minimum Diploma in relevant discipline
• 2-3 years of quality management system experience in manufacturing industry
• Experience in ISO13485

Email Address: [e-mail]

EA License No: 19C9682
EA Personnel No: R2198636
EA Personnel Name: Ong Boon Kiet (Travys)