Technomed Asia

About this position

Responsibilities

• Leads root cause analysis to resolve quality issues (complaints, non-conformities and necessary corrective and preventive actions) in collaboration with relevant departments.
• Lead process risk assessments, complete risk management plans and reports.
• Collaborate with Engineering/ TE to develop or improve quality inspections, and/or manufacturing instructions.
• Collect data and report trend analysis regarding inspection results and/ or other data related to QMS using statistical analysis.
• Support Internal and external quality audits.
• Act as a QA representative on cross-functional project teams tasked with ensuring projects are executed according to QMS with a particular focus on process control, risk management and documentation.
• Support Engineering in developing and reviewing requirements, specifications and technical documents to provide feedback from the QA side.
• Become an internal auditor and follow up on the results of the audit.
• Become a trainer for document training related to job description Quality Engineer or Quality program.

Requirements

• Education, minimum Bachelor of 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.
• Able to communicate in English, in verbally and writing.
• Proactive and looking for improvement opportunities on own initiative.
• Work independently, being able to handle complexity, handling different concurrent tasks and prioritise own work, and have the flexibility to adapt quickly to new priorities.
• Located in Kopo Katapang (Kabupaten Bandung).

Benefits