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
- Inspect and test incoming raw materials, components, and packaging materials using established procedures.
- Conduct 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).
- Record test data accurately and ensure traceability in compliance with GDP (Good Documentation Practices).
- Establish test methods and train QC inspectors to perform testing.
- 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 CAPA and change control processes.
- Collaborate with production to maintain in-process quality.
- Audit production line to ensure GMP practices and adherence to documented process instructions.
- Escalate quality issues to QC Supervisor/Quality Engineer for disposition.
- Participate in equipment calibration and preventive maintenance programs.
- Support process validations and verification activities.
- 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.
- 1–2 years of progressive Quality responsibility preferably in Medical Device / Pharmaceutical Manufacturing.
- Excellent communication skills; English written & oral communication skills are a must.
- 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.
- Willingness to work in a multicultural team and in a clean room environment.