Quality Assurance QA Engineer

Quality Engineer role in the Quality Department, responsible for managing customer feedback, quality issues, and compliance with medical device quality standards.

• Manage and follow up on customer feedback, complaints, and quality issues, ensuring timely investigation, root cause analysis, corrective actions, and resolution.

• Establish, maintain, and improve inspection criteria, specifications, and quality standards for incoming materials, in-process production, and finished products.

• Identify, document, and manage product quality issues and Non-Conformances (NCRs), including root cause analysis and corrective/preventive actions.

• Authorize product release, review and approve Certificates of Conformance (COC), Certificates of Analysis (COA), and inspection results.

• Review and approve Device History Records (DHR) to ensure compliance with established requirements.

• Develop, implement, review, and maintain quality procedures, work instructions, inspection methods, and quality control measures.

• Support and participate in internal audits, external audits, and customer audits.

• Conduct analysis of product quality data and quality objectives, identifying trends and improvement opportunities.

• Degree or diploma in Chemical, Material, Manufacturing, Science and Engineering, or a related discipline.

• 2-5 years' experience in medical device Quality Assurance. Fresh graduates are welcomed.

• Strong analytical, problem-solving, critical-thinking skills and the ability to demonstrate initiative.

• Proficient in Microsoft Office applications, with familiarity in quality control tools and knowledge of ISO 13485 and/or ISO 9001 requirements.

• ISO 13485:2016 certified internal auditor will be advantageous.