Technician, Quality Engineering

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

## Technician, Quality EngineeringApply: Singapore, Singapore: Full time: Posted Today**Our Culture** We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need. Job Summary:• Responsible to maintain Product Quality within Quasar Medical, Singapore Operations. This will include support for new product development and transfers.Essential Duties and Responsibilities:• Maintain the requirements of ISO13485, GMP, FDA 820 and other applicable regulations.• Participate in the internal and external audit programs as required.• Supporting NC, CAPA, customer complaint activities.• Preparing document related to product specifications, test methods, processes, validations etc.• Assist in Test Method Validation establishment and execution.• Supporting the data analysis process during validation.• Responsible for the management of the equipment calibration in Quasar Medical Singapore.• Participate in QA initiatives or cost improvement project• Participate in new product introductions• Maintaining equipment calibration system and coordinating with service provider for the equipment calibration.Authority:• To approve on calibration certificate.Education/Experience and Qualifications:• Degree/Diploma in Engineering or science, preferable with at least 1 years of working experiences on Quality related role.• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards is preferable.• Good command of English language.• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.• Able to effectively collaborate with cross-functional teams and present information clearly.Work Environment:• Controlled Environment (Class 10K/100K cleanroom) and office area.