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