A Production Manager

5 days ago

Masai, Malaysia SUPER HERO FAMILY ENTERPRISE Full time

1. Production Planning & Control:

- Develop and execute daily, weekly, and monthly production plans to meet customer demand.
- Optimize molding and assembly line efficiency while ensuring mínimal downtime and waste.
- Monitor production KPIs (output, yield, OEE, etc.) and implement corrective actions where necessary.

2. Quality & Compliance:

- Ensure all products meet regulatory (e.g. ISO 13485, FDA) and customer quality standards.
- Support cleanroom operations and maintain GMP standards.
- Lead root cause analysis and implement corrective/preventive actions (CAPA) for quality issues.

3. Management (People, Process & Equipment):

- Supervise and train production staff (technicians, operators) in molding and assembly areas.
- Build a high-performing team culture with a focus on safety, quality, and continuous improvement.
- Manage injection molding machines, tooling, and automation equipment used in assembly.
- Work closely 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 manufacturing initiatives to improve productivity and reduce cost.
- Analyze production data to identify bottlenecks and drive operational excellence.

5. Customer & Cross-Functional Communication:

- Collaborate with quality, engineering, NPI, and supply chain to ensure smooth project transitions and stable production.
- Interface with customers or auditors during visits, audits, or investigations.

6. Documentation & Reporting:

- Maintain accurate production records, batch history files, and equipment logs.
- Generate daily/weekly reports for upper management review.

7. Safety & Cleanroom Protocols:

- Enforce EHS policies and ensure safe practices in cleanroom and general production areas.
- 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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