Job Description

JOB AND RESPONSIBILITIES

1. Machine Operation & Monitoring
i) Operate automated and semi-automated facemask production machinery, including ultrasonic welding, ear-loop attaching, and folding stations.
ii) Monitor machine parameters such as temperature, pressure, and alignment to ensure consistent mask quality.
iii) Adjust machine settings as necessary to correct deviations and ensure smooth operations.

2. Material Handling & Preparation
i) Prepare and load raw materials such as melt-blown fabric, spun bond layers, nose wires, and ear loops into appropriate feeders or compartments.
ii) Verify material specifications, batch numbers, and expiry dates according to production planning and traceability requirements.
iii) Conduct pre-use inspections to ensure no contamination or defects in raw materials.

3. Quality Assurance & Product Inspection
i) Conduct routine visual and tactile inspections of facemasks for defects such as poor sealing, ear loop detachment, incorrect folding, or contamination.
ii) Measure product dimensions using standard tools (e.g., rulers, gauges) to ensure compliance with product specifications.
iii) Isolate and document defective items following Non-Conformance Report (NCR) procedures.

4. Compliance with Quality & Regulatory Standards
i) Adhere strictly to ISO 13485, GMP, and internal SOPs related to medical device production.
ii) Follow cleanroom protocols including gowning procedures, personal hygiene, and restricted movement policies.
iii) Ensure all documentation is completed accurately, legibly, and in real-time.

5. Equipment Maintenance & Basic Troubleshooting
i) Perform daily, weekly, and monthly machine checks and preventive maintenance tasks (e.g., cleaning filters, checking belts).
ii) Identify early signs of wear and tear, vibration, or abnormal machine sounds and report them to the Maintenance team.
iii) Assist technicians during scheduled maintenance and equipment calibration.

6. Production Reporting & Recordkeeping
i) Record production quantities, downtime reasons, machine performance, and material usage in batch records or logbooks.
ii) Update shift handover reports to ensure continuity and transparency of operations.
iii) Participate in inventory control by monitoring material usage and highlighting potential shortages.

7. Line Clearance & Changeover Activities
i) Conduct line clearance before and after production batches to prevent cross-contamination.
ii) Support efficient product changeover by dismantling and replacing components as required.
iii) Label and segregate product types appropriately according to shift or batch.

8. Health, Safety, and Environmental Compliance
i) Maintain a safe and clean working area in compliance with HSE policies.
ii) Report safety hazards, near misses, and incidents immediately to the supervisor.
iii) Use personal protective equipment (PPE) correctly at all times in the production area.

9. Continuous Improvement & Team Collaboration
i) Participate in 5S, and other lean manufacturing initiatives to improve efficiency and reduce waste.
ii) Provide input during production meetings on performance issues and suggest improvement opportunities.
iii) Train or guide junior technicians or new joiners under supervision when needed.

10. Support During Audits & Inspections
i) Assist during internal and external audits (e.g., by MOH, MDA, SIRIM) by providing necessary records and demonstrating compliance.
ii) Implement corrective and preventive actions (CAPA) based on audit findings as directed.

Qualifications and Requirements:

Certificate/Diploma in Mechanical Engineering, Mechatronics, Manufacturing Technology, or related technical field. Additional training or certification in machine operation, quality control, or medical device manufacturing will be an advantage. Minimum

2 years of hands-on experience

operating machinery in a

medical or regulated manufacturing environment

, ideally in

facemask or PPE production

. Experience working in a

cleanroom

or

controlled environment

following

GMP

or

ISO 13485

standards. Familiarity with

automated facemask production machines

(e.g., ultrasonic welding, ear-loop attachment, mask folding). Knowledge of

Good Manufacturing Practice (GMP)

and

ISO 13485:2016

standards. Willingness to

adapt to shift work, weekend duties, or overtime

when necessary.
Job Type: Full-time

Pay: RM1,453.33 - RM3,121.02 per month

Benefits:

Free parking
Ability to commute/relocate:

Sungai Petani: Reliably commute or planning to relocate before starting work (Preferred)
Experience:

Electrical wiring: 1 year (Preferred)
Work Location: In person