Job Description

:

1. Daily Production Oversight

? Supervise day-to-day operations of injection molding and manual/automated assembly lines.

? Ensure production schedules are met with high efficiency and product quality.

? Coordinate manpower, material, and machine resources to optimize productivity.

2. Quality & Compliance

? Enforce compliance with ISO 13485, GMP, and relevant FDA Class I & II regulatory standards.

? Ensure proper gowning, cleanroom behavior, and hygiene practices are followed at all times.

? Conduct in-process checks and support QA during inspections and audits.

3. Team Supervision & Training

? Lead, coach, and develop a team of operators and technicians.

? Conduct on-the-job training for SOPs, work instructions, safety procedures, and product handling.

? Monitor operator performance and discipline, ensuring adherence to work standards.

4. Process Control

? Monitor molding parameters and assembly processes to maintain product consistency.

? Identify and escalate process deviations or equipment issues to engineers or maintenance teams.

? Ensure proper setup, first article checks, and lot start-up verification are performed.

5. Documentation & Traceability

? Ensure accurate and timely completion of production-related documents such as:

? Batch records / travelers

? Lot traceability logs

? Downtime reports

? Equipment logs

6. Cleanroom & Safety Management

? Maintain Class 100K cleanroom discipline, materials flow, and contamination control.

? Conduct routine checks to ensure a safe working environment and compliance with EHS policies.

? Report and respond to incidents or safety violations promptly.

7. Communication & Coordination

? Coordinate with QA, maintenance, engineering, and planning teams to resolve issues.

? Attend daily production meetings and provide updates on output, yield, and issues.

? Support NPI builds and process validation runs when required.

Job Requirements:

? Diploma or Degree in Manufacturing, Engineering, or related field

? Minimum 5 years of experience in injection molding and/or assembly production

? At least 2-3 years of supervisory experience in a manufacturing environment

? Familiar with daily production scheduling, manpower planning, and output tracking

? Hands-on experience in injection molding parameters and process setup

? Knowledge of ISO 13485, GMP, and FDA (Class I & II) compliance requirements

? Experienced in cleanroom operations, including gowning, hygiene, and material flow control

? Able to supervise and train production operators, technician teams, and line leaders

? Skilled in conducting in-process checks and coordinating with QA for inspections and audits

? Capable of troubleshooting minor process issues and escalating major deviations to Engineering

? Familiar with documentation such as batch records, lot traceability logs, and downtime reports

? Proactive in implementing 5S, safety measures, and enforcing EHS policies

? Strong communication skills and ability to work cross-functionally with QA, Maintenance, and Planning teams

? Willing to support new product builds (NPI) and validation runs as needed

Job Type: Permanent

Pay: RM5,000.00 - RM7,500.00 per month

Benefits:

Professional development
Work Location: In person