Quality Engineering Technician - ISO/FDA Compliance

Quasar Medical; Singapore; On-site; SGD 42,000 - 60,000; Full time

Job summary

Quasar Medical in Singapore seeks a Technician in Quality Engineering to uphold product quality within the Singapore operations. The role spans support for new product development and transfers, ensuring regulatory compliance and smooth QA processes.

The technician will work under ISO13485, GMP, FDA 820 guidelines, participate in audits, and support CAPA, NC, and customer complaints, with emphasis on calibration and documentation.

Qualifications

• Degree/Diploma in Engineering or science, with at least 1 year of quality-related experience.
• Familiarity with FDA, ISO 13485; regulatory knowledge preferred.
• Good command of English; strong analytical and problem-solving abilities.

Responsibilities

• Maintain ISO13485, GMP, FDA 820 and related regulations.
• Participate in internal and external audit programs as required.
• Support NC, CAPA and customer complaint activities.
• Prepare documentation for product specs, test methods and processes.
• Assist in Test Method Validation setup and execution.
• Support data analysis during validation.
• Manage equipment calibration in Quasar Medical Singapore.
• Contribute to QA initiatives or cost-improvement projects.
• Participate in new product introductions.
• Maintain calibration system and coordinate with service providers.

Skills

Analytical skills

Problem solving

Cross-functional collaboration

Education

Engineering or science degree

Job description

Quasar Medical in Singapore seeks a Technician in Quality Engineering to uphold product quality within the Singapore operations. The role spans support for new product development and transfers, ensuring regulatory compliance and smooth QA processes.

The technician will work under ISO13485, GMP, FDA 820 guidelines, participate in audits, and support CAPA, NC, and customer complaints, with emphasis on calibration and documentation.