Incoming Quality Engineer
Masimo
- Johor Bahru, Johor
- Permanent
- Full-time
- 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 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.
- 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