QC Technician
2 days ago
Job Summary:
The QC 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
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