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