Quality Assurance QA Engineer

Fuku by Momofuku; Singapore; Sur place; SGD 60 000 - 110 000; Plein temps

Résumé du poste

Fuku by Momofuku in Singapore is seeking a Quality Engineer to join the Quality Department. You will manage customer feedback, investigate quality issues, and ensure compliance with medical device quality standards.

You will establish inspection criteria for incoming materials, in-process production, and finished products, review DHRs, COAs, and COCs, and support audits to drive continual improvement.

Qualifications

• 2-5 years' experience in medical device Quality Assurance. Fresh graduates are welcomed.
• Strong analytical and problem-solving skills with initiative.
• Familiarity with quality control tools and documentation practices.
• Knowledge of ISO 13485 and related medical device quality standards is a plus.

Responsabilités

• Manage and follow up on customer feedback, complaints, and quality issues with root cause analysis and timely resolution.
• Establish, maintain, and improve inspection criteria for incoming materials, in-process production, and finished products.
• Identify, document, and manage NCRs including CAPA activities.
• Authorize release and review COCs, COAs, and inspection results; review DHRs for compliance.

Connaissances

Analytical thinking

Problem-solving

Critical thinking

Initiative

Formation

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

Outils

Microsoft Office

ISO 13485 knowledge

ISO 9001 knowledge

Description du poste

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.