Quality Assurance QA Engineer

About the role

Fuku is hiring a Quality Assurance QA Engineer for its Quality Department in Singapore. The role manages customer feedback and quality issues and ensures compliance with medical device quality standards.

Key responsibilities

• Follow up on customer feedback, complaints and quality issues, ensuring timely investigation, root cause analysis, corrective actions and resolution.
• Set, maintain and improve inspection criteria, specifications and quality standards for incoming materials, in-process production and finished products.
• Document and manage product quality issues and non-conformances (NCRs), including root cause analysis and corrective and preventive actions.
• Authorize product release and review and approve Certificates of Conformance (COC), Certificates of Analysis (COA) and inspection results.
• Review and approve Device History Records (DHR).
• Develop, implement, review and maintain quality procedures, work instructions, inspection methods and quality control measures.
• Support internal, external and customer audits.
• Analyse product quality data and quality objectives to identify trends and improvement opportunities.

Required profile

• Degree or diploma in Chemical, Material, Manufacturing, Science and Engineering or a related discipline.
• 2-5 years of experience in medical device Quality Assurance; fresh graduates are welcomed.
• Strong analytical, problem-solving and critical-thinking skills, with initiative.
• Knowledge of ISO 13485 and/or ISO 9001 requirements; ISO 13485:2016 certified internal auditor status is advantageous.

Required skills

• Proficiency in Microsoft Office applications.
• Familiarity with quality control tools.