- Singapore
Lumina Advisory & Global Search Hiring! Full Time Quality Assurance (QA) Engineer in - Ricebowl
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Job Description
Responsibilities
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
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.
- 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.
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