Supplier Quality Engineer

Company Background:

A global medical technology company specializing in innovative noninvasive monitoring solutions and advanced healthcare technologies. The organization is committed to improving patient outcomes and reducing the cost of care by developing cutting-edge devices and systems used in hospitals clinics and homecare settings. With operations in Malaysia it supports engineering manufacturing and R&D activities adhering strictly to international standards.

Job Summary:

Responsible for managing supplier quality to ensure materials and components meet company specifications regulatory standards and business requirements. Involves supplier selection qualification monitoring and continuous improvement.

Key Responsibilities:

• Evaluate approve and manage supplier performance
• Work with suppliers to establish quality requirements and process controls
• Conduct supplier audits (quality system process and product)
• Support supplier qualification process validation and first article approval
• Monitor supplier quality metrics and drive improvement initiatives
• Investigate non-conforming materials and ensure corrective actions
• Collaborate with engineering manufacturing and quality teams on supplier-related issues
• Support incoming inspection and resolve customer return issues linked to suppliers

Job Requirements:

• Degree in Engineering or related field
• Minimum 3 years of experience in quality engineering or supplier management (preferably medical device or regulated industry)
• Knowledge of manufacturing processes and quality standards (ISO 13485 ISO 9001 FDA QSR)
• Experience in supplier audits and quality tools (e.g. risk analysis 8D)
• Strong problem-solving analytical and communication skills
• Ability to work independently and manage multiple tasks
• Willing to travel up to 25%

Location: Pasir Gudang
Salary Range: RM7k - RM10k
PIC contact no: Bee Ser 012-5752679