Editorial summary

The company is seeking a Senior/QA Engineer (Medical Device) to oversee product and process quality, investigate non-conformances, and implement corrective and preventive actions (CAPA). The role requires ensuring compliance with FDA and ISO 13485 standards, supporting internal and external audits, and participating in product transfers, NPI, and validation activities (IQ/OQ/PQ). The position emphasizes root cause analysis and driving continuous improvement to enhance quality and manufacturing performance, with compensation listed at 5,500.

This summary is AI-generated and may contain inaccuracies. Please refer to the full job description below.

Job description

[This job https://singapore.job-q.com/jobs/detail/senior-qa-engineer-medical-device-42410 first appeared in Job-Q.com on 10 Nov 2026]

Key Responsibilities

• Monitor product and process quality, investigate non-conformances, and implement corrective and preventive actions (CAPA).
• Ensure compliance with FDA, ISO 13485, and company quality management system requirements.
• Support internal audits, external audits, and regulatory inspections.
• Participate in product transfers, new product introductions (NPI), and validation activities (IQ/OQ/PQ, process and test method validation).
• Conduct root cause analysis and drive continuous improvement initiatives to enhance quality and manufacturing performance.
• Manage customer quality issues, complaints, and change notifications.
• Maintain quality documentation, reports, and traceability records.
• Train and support manufacturing teams on quality standards and best practices.

Requirements

• Degree or Diploma in Engineering, Science, or a related discipline.
• 2–5 years of quality experience in medical device, pharmaceutical, or regulated manufacturing environments.
• Knowledge of FDA regulations, ISO 13485, CAPA, root cause analysis, and quality management systems.

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Jacqueline Goh

EA License Number: 22C1430

Registration Number: R1326664

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