# Quality Assurance QA Engineer at Fuku

> Singapore · Unspecified · QA / Test · open. Source: https://alderhq.app/jobs/workable%3Afuku%3A1F9C67A760 (read 2026-11-13).

## Facts (observed)

- Company: [Fuku](https://alderhq.app/companies/fuku)
- Location text: Singapore, Singapore, Singapore
- Where it can be done from (inferred): Singapore (evidence: "Location: Singapore, Singapore, Singapore")
- Posted: 2026-11-12 (1 days ago)
- First seen by alder: 2026-11-12 · last verified: 2026-11-12
- Reposted: 0 times · edited: 0 times
- Apply on the employer's site: https://apply.workable.com/j/1F9C67A760

## Pay and sponsorship

- Posted pay: not posted

## Description (the employer's text)

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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Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/workable%3Afuku%3A1F9C67A760 and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.