QMS Engineer (ISO 13485)

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
• 3 years of quality management system experience in manufacturing industry
• Experience in both ISO 9001 & ISO13485
• Must be certified as Internal Quality Auditor for ISO 13485 / ISO 9001

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/CV.

We regret that only shortlisted candidates will be notified.

Email Address: [email protected]
EA License No: 19C9682
EA Personnel No: R22104769
EA Personnel Name: Ong Boon Kiet (Travys)