Quality Assurance Engineer
About this position
The Quality Assurance Engineer is responsible for leading quality improvement initiatives, conducting risk assessments, and collaborating with various departments to ensure compliance with quality management systems.
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).