QMS Engineer / Senior Manufacturing Engineer (ISO13485)

Our client is one of the leading companies in the Contract Manufacturing industry. Due to their current expansion plan, they are looking for Senior Manufacturing Engineer / QMS Engineer to join their Engineering team, in hopes of developing the current high performing team. They are located in the North – easily accessible.

Role 1: QMS Engineer

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

Role 1: Senior Manufacturing Engineer

The Senior Manufacturing Engineer's responsible is:

• Provide technical leadership and support for molding, assembly, or automation processes, including troubleshooting complex production issues.
• Apply scientific molding and structured problem-solving methods to improve process stability, yield, and overall manufacturing performance.
• Lead root cause investigations and implement corrective and preventive actions to reduce defects, scrap, and rework.
• Manage process validations (IQ, OQ, PQ), tooling trials, and Engineering Change Notifications (ECN) to ensure smooth implementation of product or process changes.
• Drive continuous improvement initiatives to enhance OEE, optimize cycle time, and improve cost efficiency through lean and automation practices.
• Collaborate with cross-functional teams, suppliers, and customers on technical clarifications, process improvements, and compliance with quality and regulatory standards (e.g., ISO 13485, FDA QSR).

Requirement

• Minimum 5 years of hands on manufacturing engineering experience in Molding industry
• Diploma / Degree in Engineering field

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)