Job Description:
1. Production Planning & Control:
o Develop and execute daily, weekly, and monthly production plans to meet customer demand.
o Optimize molding and assembly line efficiency while ensuring minimal downtime and waste.
o Monitor production KPIs (output, yield, OEE, etc.) and implement corrective actions where necessary.
2. Quality & Compliance:
o Ensure all products meet regulatory (e.g. ISO 13485, FDA) and customer quality standards.
o Support cleanroom operations and maintain GMP standards.
o Lead root cause analysis and implement corrective/preventive actions (CAPA) for quality issues.
3. Management (People, Process & Equipment):
o Supervise and train production staff (technicians, operators) in molding and assembly areas.
o Build a high-performing team culture with a focus on safety, quality, and continuous improvement.
o Manage injection molding machines, tooling, and automation equipment used in assembly.
o Work closely with engineering and maintenance to ensure equipment reliability and process optimization.
o Oversee validation activities (IQ/OQ/PQ) for molding and assembly processes.
4. Continuous Improvement & Lean Manufacturing:
o Lead Kaizen, 5S, and lean manufacturing initiatives to improve productivity and reduce cost.
o Analyze production data to identify bottlenecks and drive operational excellence.
5. Customer & Cross-Functional Communication:
o Collaborate with quality, engineering, NPI, and supply chain to ensure smooth project transitions and stable production.
o Interface with customers or auditors during visits, audits, or investigations.
6. Documentation & Reporting:
o Maintain accurate production records, batch history files, and equipment logs.
o Generate daily/weekly reports for upper management review.
7. Safety & Cleanroom Protocols:
o Enforce EHS policies and ensure safe practices in cleanroom and general production areas.
o Ensure gowning, material flow, and cleanroom behavior complies with procedures.
Job Requirements:
- Bachelor’s Degree in related fields
- Minimum 8 years of manufacturing experience, with at least 5 years in a managerial role
- Hands-on experience in injection molding and assembly operations is essential
- Exposure to medical device manufacturing or cleanroom-controlled environments is a strong advantage
- Solid knowledge of ISO 13485, GMP, and FDA (21 CFR Part 820) regulatory standards
- Experienced in leading CAPA, root cause analysis, and process validation (IQ/OQ/PQ)
- Proficient in production planning, resource allocation, and managing production KPIs (OEE, yield, downtime)
- Strong leadership and team development skills – able to coach and supervise operators, technicians, and supervisors
- Familiar with operation and maintenance of molding machines, tooling, and automation equipment
- Experience in Lean Manufacturing, Kaizen, and 5S implementation
- Good cross-functional collaboration with QA, Engineering, Supply Chain, and NPI teams
- Competent in preparing production reports, equipment logs, and maintaining batch records
- Knowledge of cleanroom discipline, material flow, and hygiene practices
- Excellent communication and stakeholder engagement skills, including auditors and customers
Job Type: Permanent
Pay: RM10,000.00 - RM15,000.00 per month
Benefits:
- Professional development
Work Location: In person
