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
