QE Technician

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Maintain the requirements of IS013485, 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.