Technician, Quality Engineering

Quasar Medical (Singapore) pte.ltd.; Singapore; On-site; SGD 50,000 - 75,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

Analytical thinking

Problem solving

Cross-functional collaboration

Documentation & reporting

English communication

Education

Engineering or science degree

Job description

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.

Join Our Global Team

Are you passionate about helping others? Our employees are dedicated to serving medical device customers who deliver life-giving therapies around the world. We seek individuals who are enthusiastic, intelligent and thrive in teamwork, with a strong aspiration to pursue a fulfilling and impactful career. At Quasar, every day is a new opportunity to make a difference.

True To Quality

At Quasar, quality is more than just a priority – it is part of our culture. Our comprehensive development and manufacturing solutions for minimally invasive devices, catheters and sensors enable life-giving therapies for patients all over the world, and we take this responsibility seriously.

Our Mission

To earn the trust of leading medical device brands as quality supply partner with minimally invasive and innovative solutions for patients globally and locally. What we make saves lives.