QE Technician

Job Summary:

The QE technician is responsible for supporting quality activities within Quasar Medical Singapore

Operations. This will include support for new product development and transfers.

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

Inspection & Testing

• Perform / guiding QC Inspectors in conducting incoming inspection of raw materials,

components, and packaging materials using established procedures.

• Perform / guiding QC Inspectors in conducting in-process and final product inspections,

including dimensional checks, functional testing, and visual inspections.

• Operate and maintain QC instruments (e.g., calipers, micrometers, microscopes, tensile testers,

vision systems, SmartScope, etc.).

• Record test data accurately and ensure traceability in compliance with GDP (Good

Documentation Practices).

• Involve in the establishment of test method and be the trainer to guide QC inspectors

performing the testing.

Documentation & Compliance

• Complete inspection records, test reports, and nonconformance reports in accordance with ISO

13485 and FDA 21 CFR Part 820 requirements.

• Ensure proper labeling, segregation, and disposition of accepted/rejected materials.
• Assist in investigation of nonconformities, deviations, and customer complaints.
• Support Corrective and Preventive Actions (CAPA) and change control processes.

Process Support

• Collaborate with production to ensure in-process quality is maintained.
• Routinely audit the production line to ensure the GMP practices is in place, and operators are

following documented process instruction.

• Escalate quality issues to QC Supervisor/Quality Engineer for disposition.
• Participate in equipment calibration and preventive maintenance programs.
• Support process validations and verification activities.

Continuous Improvement

• Contribute to improvement of inspection methods and sampling plans.
• Provide feedback to engineering and production teams on quality issues and trends.
• Participate in internal audits, training, and quality improvement initiatives.

Education/Experience and Qualifications:

• GCE “O” level or equivalent, Diploma preferred, with 1~2 years of progressive Quality

responsibility preferably in Medical Device / Pharmaceutical Manufacturing.

• Excellent Communication Skills. English written & oral communication skills are a must.
• Computer literate (MS Office).
• Knowledgeable in reading and/ or writing manufacturing procedures and GMP requirements.
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO

13485 standards is a plus.

• Willing to work in a multi-cultural team and in a clean room environment.
• Willing to work in shift