Quality Engineering Technician - Medical Devices (ISO 13485)

Quasar Medical (Singapore) pte.ltd.; Singapore; Presencial; SGD 50.000 - 75.000; Jornada completa

Descripción de la vacante

Quasar Medical (Singapore) pte.ltd. is seeking a Quality professional to maintain product quality within Singapore operations, including support for new product development and transfers.

You will ensure compliance with ISO13485, GMP and FDA 820, participate in audits, and support NC, CAPA and customer complaint activities.

The role emphasizes strong analytical skills, cross-functional collaboration, and clear documentation in a controlled cleanroom environment.

Formación

• Bachelor or diploma in engineering or science with quality exposure.
• Knowledge of FDA regulations and ISO 13485 preferable.
• Strong analytical and troubleshooting abilities.

Responsabilidades

• Maintain ISO13485, GMP, FDA 820 compliance.
• Support internal and external audits.
• Assist NC, CAPA and customer complaint activities.
• Prepare docs for specifications, test methods and validations.
• Assist in Test Method Validation establishment.
• Support data analysis during validation.
• Manage calibration at Quasar Singapore.
• Participate in QA initiatives and cost improvements.
• Assist in new product introductions.
• Maintain calibration system; coordinate with service providers.

Conocimientos

Analytical thinking

Problem solving

Cross-functional collaboration

Documentation & reporting

English communication

Educación

Engineering or science degree

Descripción del empleo

Quasar Medical (Singapore) pte.ltd. is seeking a Quality professional to maintain product quality within Singapore operations, including support for new product development and transfers.

You will ensure compliance with ISO13485, GMP and FDA 820, participate in audits, and support NC, CAPA and customer complaint activities.

The role emphasizes strong analytical skills, cross-functional collaboration, and clear documentation in a controlled cleanroom environment.