Technician - Quality (13909)

Technician 2: IMTE Calibration & Preventive Maintenance Technician

Key Functions: Execute preventive maintenance and calibrate all OAQ IMTE across 2 Campus/3 Buildings (B12, B9 & B3), consisting of 10 OAQ Labs [CPCS, Molding, IVC, Needle & EIS]

Task Descriptions:

• Ensures equipment are calibrated according to the master schedules and meet registered industry/manufacturing standards.
• Assist calibration service provider (Internal / External) on sites for equipment calibration and perform initial equipment buyoff if the calibration meets the requirements. Else, this shall be further communicated with Engineer for next course of actions.
• Document calibration report and update calibration history card for GMP & quality compliance as this quality record shall be subjected for compliance audits.
• Coordinate with IMTE Users (stakeholders) by referencing to Preventive Maintenance Master List in monthly basis for calibration activities to avoid/minimize its impacts in routine QC operations.
• Internal PM: Perform internal maintenances and update the PM checklist.
• External PM:  Assist and ensure the external service provider shall complete the PM according to our schedule and checklist while adhering to BMI GMP protocols when carrying out job in clean room.
• The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time

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.