Technician - Quality

Follow established procedures and guidelines to check, test and inspect raw materials, goods in process and finished goods.

Compare the physical characteristics of components, materials, equipment and products to technical specifications to identify defects.

Conduct simple tests (for example on electrical function, reliability, packaging quality), record results and prepare simple technical reports.

To support In-Line Test Station (ITS) MSA activities during machine qualification.

To optimise and improve robustness of machine ITS

REQUIREMENTS:

Diploma with basic working experience.

At least 1-2 years of working experience in the medical industry.

Knowledge of ISO 13485.

FDA 21 CFR Part 820.

Task Descriptions:

lyEnsures that equipment is calibrated according to the master schedules and complies with established industry and manufacturing standards.

Assist calibration service providers (both internal and external) on-site for equipment calibration, and perform initial equipment buyoff if the calibration meets the requirements. If it does not meet the standards, this will be communicated to the engineer for further action.

Document the calibration report and update the calibration history card to ensure compliance with GMP and quality standards, as this documentation will be subject to compliance audits.

Coordinate with IMTE users (stakeholders) by referencing the Preventive Maintenance Master List on a monthly basis to manage calibration activities and minimize their impact on routine QC operations.

For internal preventive maintenance: Perform maintenance tasks and update the PM checklist according.