Production Supervisor(Molding & Assembly) (Medical Device)

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