Quality Assurance Engineer (Non IT)

Responsibilities 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.

Familiar with process risk assessments, complete risk management plans and reports.

Demonstrate knowledge of process risk assessments, including the preparation of risk management plans and related documentation.

Collaborate with cross-functional departments to support the development, improvement, and optimization of quality inspection methods and manufacturing instructions.

Perform trend analysis of inspection results and other Quality Management System (QMS) data using basic statistical analysis tools to support continuous improvement activities.

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.

Proactive and looking for improvement opportunities on own initiative.

Comfortable working independently and handling assigned tasks effectively.

Technomed Asia is a foreign owned company specialized in the production of medical accessories. Main products are electrodes for EEG (brain studies), EMG (muscle studies) and intra-operative monitoring. Technomed Asia produces accessories under the Technomed brand, as well as for several OEM customers worldwide. Its strength is the production of relatively small quantities of highly customized products. Technomed Asia has its own independent ISO 13485 certified quality system and is FDA registered as well as appointed as a manufacturer of medical accessories for the Japanese market.

Purwakarta, West Java, ID

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