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
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