Roles & Responsibilities:

• Inspect incoming raw materials and components to ensure compliance with quality specifications, particularly ISO13485 and 21 CFR 820.
• Perform manufacturing batch record and documentation review for completeness and accuracy prior to product release and/or closure.
• Manage calibration program to support measurement instruments used for product release and environmental monitoring.
• Perform environmental monitoring, measurement and publish test report.
• Performing physical non-conforming material segregation and disposition per approved instructions.
• Maintain filing system for inspection reports.
• Able to perform 12-hour (day) shift work and any other adhoc duties assigned when required.

Requirements:

• Minimum ITE or equivalent.
• Preferably 1 - 3 years QA experience in clean room environment, semiconductor / pharmaceutical / biotech industries.
• Willing to work on 12 hour shift