Assistant Engineer, Quality at Masimo in Pasir Gudang, Malaysia

Assistant Engineer, Quality

Location: Pasir Gudang, Malaysia

Job Summary:

The Assistant Engineer, Quality is responsible for ensuring end-to-end quality across the product lifecycle, including product quality assurance, supplier quality performance, and maintenance of the Quality Management System (QMS). This role collaborates with cross-functional teams to monitor product performance, manage nonconformities, support CAPA activities, ensure compliance to regulatory requirements, and drive continuous improvements.

Duties & Responsibilities:

• Perform and support incoming, in-process, and final inspections to ensure product compliance with specifications and quality requirements.
• Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities.
• Conduct investigations on product nonconformance, customer complaints, returned products, and field issues to identify root causes and corrective actions.
• Support validation activities including IQ/OQ/PQ, test method validation, sampling plans, and Gage R&R.
• Work closely with engineering and production teams to resolve product performance or reliability issues.
• Maintain product quality records, including inspection reports, validation documents, and product release data.
• Support implementation, maintenance, and continuous improvement of the QMS in compliance with ISO 13485, FDA 21 CFR 820, CMDR, MDD 93/42 EEC, and internal procedures.
• Assist in document control and maintenance of quality records including SOPs, WI, DHR and etc.
• Participate in internal and external audits, including preparation of documentation, execution support, and management of audit findings.
• Support the management review process by collecting NCR, CAPA, audit, complaint, and quality performance data.
• Assist in supplier qualification activities, including documentation review and raising First Article Inspection Reports (FAIR) requests as required.
• Monitor supplier performance, incoming inspection results, and supplier-related nonconformity trends.
• Participate in supplier NCR and SCAR investigations; help follow up on corrective action implementation and effectiveness.
• Work with suppliers to improve component quality and reduce recurring quality issues.
• Any reasonable task assigned by superior, as applicable

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Minimum 1 year of experience in manufacturing quality, product quality, QMS, and/or supplier quality.
• Familiar with ISO 13485, FDA QSR, and basic quality tools.

Preferred Qualifications:

• Strong analytical, problem-solving, and documentation skills.
• Strong organizational and time management skills.
• Good communication skills and ability to work across teams.
• Attention to detail and ability to manage multiple tasks in fast-paced environment.

Education:

Diploma/Degree in Engineering or related technical field.

Physical requirements/Work Environment

This position works in offices, laboratory and manufacturing environments. It requires frequent sitting, standing and walking. He or she needs to be able to recognize and differentiate colors. He or she must also be able to lift up to 50 pounds. Daily use of computers and other computing and digital devices is required. He or she may stand for extended periods when facilitating meetings, walking in the facilities, performing audits and laboratory testing. Some international travel is required, so a valid international travel passport is required. Also, some local is necessary, so the ability to operate a motor vehicle and maintain a valid driver license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with reals or perceived disabilities to perform the essential functions of the job described