Engineer, Quality

Masimo Corporation; Malaysia; On-site; MYR 60,000 - 85,000; Full time

Job summary

Masimo Corporation in Malaysia is seeking an Incoming Quality Engineer to ensure incoming materials meet quality standards and specifications used in manufacturing. You will implement processes to assess, inspect, and validate materials, collaborating with suppliers and internal teams to uphold quality throughout the supply chain.

The role requires hands-on measurement skills, strong analytical thinking, and experience with CAPA and risk management.

Qualifications

• Minimum 3 years in Incoming Quality.
• Proficient in root cause analysis, CAPA, and risk management.
• Experience with quality engineering in manufacturing environments.
• Ability to perform measurements with simple hand tools and optical devices.
• Strong communication and collaboration skills.

Responsibilities

• Conduct inspections of incoming materials to ensure quality standards and regulatory requirements.
• Maintain records of inspection results and deviations; collect and maintain COC and related docs.
• Collaborate with supplier quality team to address issues and improve incoming material quality.
• Train and verify use of documentation and good documentation practices across stages.
• Ensure calibration of inspection equipment and support internal audits and document control.

Skills

English communication

Analytical mindset

Root cause analysis

CAPA

Hands-on measurement

Education

Bachelor’s degree in engineering

Tools

Image measuring system

Microscope

Job description

An Incoming Quality Engineer plays a critical role in ensuring that incoming materials and components meet established quality standards and specifications. They are responsible for implementing processes and procedures to assess, inspect, and validate incoming materials for use in manufacturing processes. The role requires a combination of technical expertise, analytical skills, and a commitment to maintaining high standards of quality throughout the supply chain.

Duties & Responsibilities:

Conduct thorough inspections of incoming materials and components to ensure they meet established quality standards, specifications, and regulatory requirements.

Maintain accurate records of inspection results, test data, and any deviations from quality standards. Collect & maintain COC and all docs related to incoming material. Document non-conforming materials and initiate appropriate corrective actions.

Collaborate with supplier quality team to address quality issues, improve incoming material quality, and establish effective communication channels for resolving quality-related concerns.

Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.

Ensure and monitor the applicable documents for Quality inspection are available in the point of use, this includes, but is not limited to the visual aids with physical samples.

Continuously assess and improve incoming quality inspection processes to enhance efficiency, accuracy, and reliability. Identify opportunities for automation and optimization to streamline workflows

Provide training and guidance to employees involved in the incoming quality inspection process. Ensure that team members understand quality standards, inspection procedures, and best practices.

Ensure that all Inspection Equipment that requires calibration, is calibrated.

Assist in Quality System activities such as: follow PDA process, Internal Audits, Internal Observations, Document Control and providing data for reports.

Actively participate in continuous improvement initiatives aimed at enhancing overall product quality, customer satisfaction, and operational excellence.

Any reasonable task assigned by Superior from time to time

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

Minimum experience of 3 years in Incoming Quality.

Good English communication skills, written and speaking.

Previous experience in quality engineering, supplier quality management, or a related role within a manufacturing environment

Ability to Perform measurement hands-on using simple handtools, microscope, Image measuring system

Excellent communication skills and the ability to collaborate effectively with internal and external team.

Analytical mindset with strong problem-solving skills and attention to detail.

Experience with root cause analysis, corrective and preventive action (CAPA) processes, and risk management methodologies.

Preferred Qualifications:

Proficiency in Microsoft office knowledge

• Experience in Risk Management to ISO 14971 and IEC 60601-1, 3rd Edition, ISO13485 and FDA regulations (will be added advantage)
• Strong knowledge of quality management principles, statistical analysis, and quality inspection techniques
• Certified as an ISO internal auditor should be advantageous

Education:

Bachelor’s degree in engineering is required and or other related equivalent.

Physical requirements/Work Environment

This position works in office, laboratory and manufacturing environments. It requires frequent sitting, standing, and walking. He or she needs to be able to recognize and differentiate color. He or she must also be able to lift up to 50 pounds. Daily use of computer 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. 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