Supplier Quality Engineer / Manufacturing Engineer (Multiple Opening)

Position 1: Supplier Quality Engineer
- (Tubing, Catheters, plastic Mold, Medical Devices)

Our client is a leading medical device manufacturing solutions provider. Due to business needs, they are now recruiting a Supplier Quality Engineer to be part of their Quality team. They are located in the North – easily accessible.

Responsibilities:

• Evaluate, qualify and requalify suppliers based on quality systems, manufacturing capabilities and regulatory compliance, while maintaining the Approved Supplier List.
• Conduct supplier audits, monitor performance metrics and identify opportunities to improve supplier quality, reliability and operational efficiency.
• Manage supplier corrective and preventive action requests (SCAR/CAPA), including root cause analysis, containment measures and timely resolution of non-conformities.
• Develop and maintain supplier quality assurance plans, inspection procedures and risk mitigation strategies to address supply chain and quality risks.
• Ensure supplier compliance with FDA regulations, ISO 13485 and applicable quality requirements, while supporting audits, new product introductions, engineering changes and continuous improvement initiatives.
• Collaborate with Engineering, Procurement and Production teams to resolve material-related quality issues, minimise production disruptions and drive cost improvement projects.
• Prepare quality reports, analyse supplier performance trends and ensure proper documentation and traceability throughout the manufacturing process.

Requirements:

• Degree in Engineering or Science with 2–5 years of quality-related experience, preferably in supplier quality within medical device or pharmaceutical manufacturing. Diploma holders with more than 5 years of relevant Supplier Quality experience may be considered.
• Knowledge of FDA regulations, ISO 13485 and supplier quality management systems.
• Experience in supplier audits, supplier qualification, corrective and preventive actions, and non-conformance management.
• Strong analytical and problem-solving capabilities, with the ability to investigate quality issues and implement effective corrective actions.
• Willingness to travel occasionally to supplier sites and work in a controlled cleanroom environment.

Position 2: Senior Manufacturing Engineering (Process Engineer)
- (Tubing, Catheters, plastic Mold, Medical Devices)

Our client is a leading medical device manufacturing solutions provider. Due to business needs, they are now recruiting a Senior Manufacturing Engineering to be part of their Engineering team. They are located in the North – easily accessible.

Responsibilities:

• Develop, evaluate and optimise manufacturing processes for new product introductions, product transfers, process changes and existing production operations.
• Design and implement tooling, fixtures and assembly methods to improve manufacturing efficiency, product quality, throughput and production capacity.
• Lead process, equipment and material qualification and validation activities, including preparation of validation protocols, IQ/OQ documentation and test method validation.
• Apply Design of Experiments (DOE), Statistical Process Control (SPC), process capability analysis and root cause investigation to reduce defects and improve process consistency.
• Manage engineering changes, equipment maintenance coordination and manufacturing documentation to ensure production readiness and operational reliability.
• Drive continuous improvement, cost reduction and new technology initiatives while ensuring compliance with EHS, ISO 13485, GMP, FDA and applicable quality requirements.
• Lead cross-functional engineering projects, provide technical guidance to junior engineers and support knowledge transfer, training and engineering capability development.

Requirements:

• Bachelor’s degree in Engineering or a related technical discipline, with 5–8 years of experience in a high-volume manufacturing environment. Medical device manufacturing and catheter production experience are advantageous.
• Proficient in DOE, SPC, process capability analysis and control charting, with the ability to apply statistical methods to manufacturing improvements.
• Experience in process validation and qualification, FMEA, IQ/OQ, test method validation and Engineering Change Order (ECO) management.
• Proficiency in CAD software and knowledge of ISO 13485, ISO 9001, GMP, FDA requirements and medical device manufacturing standards.
• Demonstrated experience in process optimisation, manufacturing troubleshooting and continuous improvement, with the ability to lead engineering projects and guide junior team members.

Position 3: Manufacturing Engineer (Plastic Mold , Medical Devices)

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

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)