Job Responsibilities
1. Production Planning & Control
- Develop and execute daily, weekly, and monthly production plans to meet customer demand.
- Optimize molding and assembly line efficiency while minimizing downtime and waste.
- Monitor production KPIs (output, yield, OEE) and take corrective actions when necessary.
2. Quality & Compliance
- Ensure products meet ISO 13485, FDA, and customer quality standards.
- Support cleanroom operations and maintain GMP compliance.
- Lead root cause analysis and implement corrective and preventive actions (CAPA).
3. Management – People, Process & Equipment
- Supervise and train production staff (technicians, operators) in molding and assembly areas.
- Build a high-performance team culture focused on safety, quality, and continuous improvement.
- Manage injection molding machines, tooling, and assembly automation equipment.
- Collaborate with engineering and maintenance to ensure equipment reliability and process optimization.
- Oversee validation activities (IQ/OQ/PQ) for molding and assembly processes.
4. Continuous Improvement & Lean Manufacturing
- Lead Kaizen, 5S, and Lean initiatives to improve productivity and reduce costs.
- Analyze production data to identify bottlenecks and drive operational excellence.
5. Customer & Cross-Functional Communication
- Work closely with quality, engineering, NPI, and supply chain teams to ensure smooth project transitions.
- Represent production during customer visits, audits, and investigations.
6. Documentation & Reporting
- Maintain accurate production records, batch history files, and equipment logs.
- Prepare daily/weekly reports for management review.
7. Safety & Cleanroom Protocols
- Enforce EHS policies and ensure safe working practices in cleanroom and production areas.
- Ensure gowning, material flow, and cleanroom behavior comply with established procedures.
Job Requirements
- Bachelor’s degree in a related field.
- Minimum 8 years of manufacturing experience, including at least 5 years in a managerial role.
- Hands-on experience in injection molding and assembly operations is essential.
- Experience in medical device manufacturing or cleanroom-controlled environments is an advantage.
- Strong knowledge of ISO 13485, GMP, and FDA (21 CFR Part 820) standards.
- Proven track record in CAPA, root cause analysis, and process validation (IQ/OQ/PQ).
- Proficient in production planning, resource allocation, and managing KPIs (OEE, yield, downtime).
- Strong leadership and team development skills; able to coach and manage operators, technicians, and supervisors.
- Familiar with molding machines, tooling, and automation equipment.
- Experience implementing Lean Manufacturing, Kaizen, and 5S practices.
- Strong collaboration skills with QA, Engineering, Supply Chain, and NPI teams.
- Competent in preparing production reports, equipment logs, and batch records.
- Knowledge of cleanroom discipline, material flow, and hygiene practices.
- Excellent communication skills for engaging with auditors, customers, and stakeholders.
Job Type: Full-time
Pay: RM10,000.00 - RM15,000.00 per month
Application Question(s):
- Have you worked in a clean-room-controlled production environment before?
Work Location: In person