Supplier Quality Engineer — Drive Compliance & Improvement

Masimo Corporation; Pasir Gudang; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading medical device company based in Malaysia is seeking a Supplier Quality Engineer to ensure compliance with quality management requirements. The role involves supplier selection, monitoring, and development, including audits and process validation. Candidates must have at least three years of experience in quality engineering, particularly in regulated industries, and possess strong analytical and problem-solving skills. The position offers an opportunity for travel and collaboration with various engineering disciplines.

Qualifications

• Minimum of three years’ experience in quality engineering and/or supplier management.
• Knowledge of manufacturing processes, procedures, and production equipment.
• Auditing experience and training (ASQ-Certified Quality Auditor or Lead Auditor Training for ISO 13485).
• Familiarity with Quality Standards (ISO 13485, ISO 9001, FDA QSR).
• Demonstrated knowledge and experience with risk analysis, statistics, and quality tools.
• Background with cables, circuit boards, circuit board assemblies and/or molding processes is a plus.
• Ability to travel (domestic & international) up to 25% of the time.

Responsibilities

• Appraise supplier credentials and survey responses.
• Route new supplier requests for approvals.
• Work with suppliers to establish process controls.
• Perform reviews with suppliers to determine manufacturability.
• Participate in development of quality requirements for components.
• Review and develop risk mitigation controls.
• Assist suppliers with investigation and process improvement.
• Perform supplier audits.
• Create supplier performance metrics and reporting.
• Ensure alignment of supplier quality metrics with business objectives.
• Dispose of nonconforming materials and follow up on corrective actions.
• Work with engineering to resolve customer return issues.
• Review and approve first articles on fabricated components.

Skills

Problem solving ability

Analytical Skills

Communication and Documentation skills

Project Management

Flexibility and adaptability

Ability to work with minimal guidance

Job description

A leading medical device company based in Malaysia is seeking a Supplier Quality Engineer to ensure compliance with quality management requirements. The role involves supplier selection, monitoring, and development, including audits and process validation. Candidates must have at least three years of experience in quality engineering, particularly in regulated industries, and possess strong analytical and problem-solving skills. The position offers an opportunity for travel and collaboration with various engineering disciplines.