About this role
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.