# Quality Assurance QA Engineer > Fuku · Singapore, Singapore · Full-time · Posted 2026-11-12 **Workplace:** on_site ## Description About the role: Quality Engineer role in the Quality Department, responsible for managing customer feedback, quality issues, and compliance with medical device quality standards. Key responsibilities: • 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. About you: • 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. ## Apply [Apply at Fuku](https://apply.workable.com/fuku/j/1F9C67A760/apply) --- Powered by [Workable](https://www.workable.com)