Supplier Quality Engineer (SQE) - Electronic components/Medical

Masimo.; Pasir Gudang; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading medical device company is seeking a Supplier Quality Engineer in Pasir Gudang, Malaysia. The role involves ensuring compliance with supplier quality standards and working closely with suppliers to meet business objectives. Candidates should have a minimum of three years' experience in quality engineering, preferably in the medical device sector. Responsibilities include performing audits, developing quality metrics, and ensuring alignment with regulatory standards. This position requires the ability to travel up to 25% domestically and internationally.

Qualifications

• Minimum of three years’ experience in quality engineering and/or supplier management.
• Familiarity with auditing standards such as ASQ certifications.
• Background in circuit boards or cable manufacturing is a plus.

Responsibilities

• Appraise supplier credentials and agreements.
• Perform supplier audits and develop performance metrics.
• Ensure compliance with quality standards and business objectives.

Skills

Quality engineering

Supplier management

Knowledge of manufacturing processes

Risk analysis and statistics

Audit experience

Education

3+ years in quality engineering or supplier management

Familiarity with ISO 13485, ISO 9001, FDA QSR

Job description

Supplier Quality Engineer (SQE) - Electronic components/Medical

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.

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.

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