Engineer, Supplier Quality

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

Supplier Quality Engineer (SQE) is responsible for ensuring: compliance with Masimo’s supplier quality management requirements; commodities meet Masimo’s specifications, business requirements are met and all applicable regulatory requirements are fulfilled. The SQE is responsible for supplier selection, qualification, monitoring and development activities, including qualification and surveillance audits, process validations and investigation of non-conforming materials.

Duties & Responsibilities

• Appraise supplier credentials, agreements and survey responses
• Route new supplier requests for approvals
• Work with suppliers to communicate requirements and establish process controls in alignment with Engineering, Manufacturing, Quality and Business Objectives
• Perform reviews with suppliers to determine manufacturability of components
• Participate in the development of quality requirements for purchased component/assemblies
• Review and develop risk mitigation controls for supplied parts
• Assist suppliers with investigation and process improvement initiatives
• Perform supplier audits (quality system, process and product audits)
• Create supplier performance metrics and report on performance to suppliers and management.
• Ensure alignment of supplier quality metrics with business objectives
• Disposition nonconforming materials and initiate follow up activities to ensure proper corrective action and preclude recurrence of rejections.
• Work with various engineering disciplines to resolve customer return issues related to supplier quality.
• Work with incoming inspection to ensure proper part surveillance.
• Review and approve first articles on custom fabricated components.

Skills required

• Strong problem solving ability
• Strong Analytical Skills
• Strong Communication and Documentation skills
• Project Management
• Flexibility and adaptability
• Ability to work with minimal guidance from direct supervisor.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• Minimum of three years’ experience in quality engineering and/or supplier management, preferably in the medical device industry (note: Supplier management experience in a highly controlled or regulated industry may be considered);
• Knowledge of manufacturing processes, procedures and production equipment;
• Auditing experience and training (ASQ-Certified Quality Auditor and or Lead Auditor Training for ISO 13485
• Familiarity with Quality Standards (ISO 13485, ISO 9001, FDA QSR, etc.)
• Demonstrated knowledge and experience with risk analysis, statistics and quality tools;
• Background with cables, circuit boards, circuit board assemblies and/or molding processes are a plus;
• Ability to travel (domestic & international) up to 25% of the time;
• Strong problem solving ability;
• Strong Analytical Skills;
• Project Management;
• Flexibility and adaptability;
• Ability to work with minimal guidance from direct supervisor;

Job Info

• Job Identification 3213
• Job Category Supplier Quality Engineering