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Fuku

Quality Assurance QA Engineer

Fuku Singapore, Singapore

Retail Apparel and Fashion · 2-10 employees

5 h ago
qa Mid (2-5 yrs) Full-time Singapore
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About the role

The Quality Assurance Engineer manages customer feedback, quality issues, and non-conformances while ensuring compliance with medical device standards. They are responsible for maintaining inspection criteria, reviewing quality documentation, and supporting internal and external audits.

What they look for

Quality Assurance Medical Device Quality Standards Root Cause Analysis Corrective Actions ISO 13485 ISO 9001 Non-Conformance Management Inspection Criteria Device History Records Quality Control Data Analysis Internal Auditing Microsoft Office Compliance Manufacturing Engineering

Requirements

Candidates must hold a degree or diploma in a relevant engineering or science discipline with 2-5 years of experience in medical device quality assurance. Proficiency in Microsoft Office and knowledge of ISO 13485 or ISO 9001 standards are required.

Full 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.

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