Quality Assurance Engineer (Non IT)

Deskripsi Pekerjaan

Job Description:

1. Lead root cause analyses to support the resolution of quality issues, including customer complaints and non-conformities, and assist in implementing corrective and preventive actions (CAPA) in collaboration with cross-functional teams.
2. Familiar with process risk assessments, complete risk management plans and reports.
3. Demonstrate knowledge of process risk assessments, including the preparation of risk management plans and related documentation.
4. Collaborate with cross-functional departments to support the development, improvement, and optimization of quality inspection methods and manufacturing instructions.
5. Perform trend analysis of inspection results and other Quality Management System (QMS) data using basic statistical analysis tools to support continuous improvement activities.
6. Possess a solid understanding of inspection and validation activities, which is considered a strong advantage.

Requirements:

• Education, minimum Bachelor of Industrial Engineering.
• Have a minimum of 5 years working experience in the QA field, preferably in the medical device industry with expertise in engineering.
• Have knowledge of how to set control limits, and complete trend analysis, with applicable statistical methods.
• Accustomed to working using data processing and analysis applications and Ms Office.
• Well-organized and understanding of the importance of good documentation
• Fluent in english
• Proactive and looking for improvement opportunities on own initiative
• Comfortable working independently and handling assigned tasks effectively
• Located in Kopo Katapang (Kabupaten Bandung)

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