Job Responsibilities
1. Daily Production Oversight
- Supervise daily operations of injection molding and manual/automated assembly lines.
- Ensure production schedules are met with high efficiency and quality standards.
- Coordinate manpower, materials, and machine resources for optimal productivity.
2. Quality & Compliance
- Ensure compliance with ISO 13485, GMP, and FDA Class I & II regulatory standards.
- Enforce proper gowning, cleanroom behavior, and hygiene practices.
- Conduct in-process checks and support QA during inspections and audits.
3. Team Supervision & Training
- Lead, coach, and develop operators and technicians.
- Provide on-the-job training on SOPs, work instructions, safety, and product handling.
- Monitor performance, discipline, and adherence to work standards.
4. Process Control
- Monitor molding parameters and assembly processes for product consistency.
- Identify and escalate process deviations or equipment issues to engineers or maintenance.
- Ensure proper setup, first article checks, and lot start-up verification.
5. Documentation & Traceability
- Complete production documents accurately, including:
- 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 safety checks and enforce EHS policies.
- Report and respond promptly to incidents or safety violations.
7. Communication & Coordination
- Coordinate with QA, maintenance, engineering, and planning teams to resolve issues.
- Attend daily production meetings and report on output, yield, and issues.
- Support new product builds (NPI) and process validation runs as needed.
Job Requirements
- Diploma or Degree in Manufacturing, Engineering, or related field.
- Minimum 5 years’ experience in injection molding and/or assembly production.
- At least 2–3 years’ supervisory experience in manufacturing.
- Skilled in daily production scheduling, manpower planning, and output tracking.
- Hands-on experience in molding parameters and process setup.
- Knowledge of ISO 13485, GMP, and FDA (Class I & II) compliance.
- Experienced in cleanroom operations (gowning, hygiene, material flow control).
- Able to supervise and train operators, technicians, and line leaders.
- Skilled in in-process checks and coordinating QA inspections and audits.
- Capable of troubleshooting minor process issues and escalating major deviations.
- Familiar with production documentation (batch records, traceability logs, downtime reports).
- Proactive in implementing 5S, safety measures, and EHS compliance.
- Strong communication skills and cross-functional collaboration abilities.
- Willing to support NPI builds and validation runs when required.
Job Type: Full-time
Pay: RM5,000.00 - RM7,500.00 per month
Application Question(s):
- Have you worked in a clean-room-controlled production environment before?
Work Location: In person
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