Quality Assurance Engineer (CCR/CAPA)
Detail posisi
The Quality Assurance Engineer (CCR/CAPA) is responsible for managing the change control and CAPA processes at the factory, ensuring quality standards are met and maintained.
Kewajiban
• Responsible to manage the change control process of the factory in relation with the team at the headquarter.
• Representative of the QA in any change initiated through the change control process.
• Direct leader of some CCR (Change Control) related to the QA fields.
• Lead weekly follow-up meetings with the CCR project teams and headquarter.
• Responsible to manage the CAPA process of the factory.
• Lead and engage in the CAPA investigation at the factory.
• Monitoring and reporting quality-related key performance indicators.
Kualifikasi
• Education: Bachelor’s degree in science or Engineering.
• Working experience: Minimum 3-8 years in Quality Assurance field; experience in the medical product field a plus.
• Specific skill/knowledge: Previous experience in change control.
• General knowledge: Good command of English communication, computer literacy, able to lead a small team.