Regulatory Affairs à Malaisie

Company Background: A new manufacturing facility is being established in Senai Ipark, Johor Bahru, specializing in medical devices, injection molding, and precision engineering. We welcome talent with relevant industry experience to apply. For the right candidate, our client is prepared to offer up to a 30% increase on your current salary.

Job Description:

1. Process Design & Optimization:
   Design and develop automated assembly processes for plastic products, ensuring efficiency and quality.
   Optimize assembly processes to reduce cycle times, minimize waste, and improve product consistency.
2. Molding & Medical Plastics Expertise:
   Apply your knowledge of molding techniques to ensure seamless integration between molding and assembly processes.
   Leverage expertise in medical plastics to meet stringent quality and regulatory requirements in the assembly of medical-grade products.
3. Automation & Equipment Management:
   Oversee the selection, setup, and maintenance of automated assembly equipment.
   Work with equipment suppliers and vendors to ensure machinery meets production needs and specifications.
4. Process Troubleshooting & Continuous Improvement:
   Diagnose and resolve issues related to assembly processes, equipment performance, and product quality.
   Lead continuous improvement initiatives aimed at enhancing assembly efficiency, reducing downtime, and improving product quality.
5. Quality Assurance:
   Collaborate with the quality team to ensure that all assembled products meet or exceed quality standards.
   Implement and monitor process controls to maintain consistent product quality throughout the assembly process.
6. Documentation & Reporting:
   Maintain detailed documentation of assembly processes, equipment settings, and standard operating procedures (SOPs).
   Prepare reports on process performance, including recommendations for improvements.
7. Cross-Functional Collaboration:
   Work closely with the production, R&D, and quality teams to support new product development and ongoing production.
   Provide technical support and training to assembly line operators and technicians.
8. Regulatory Compliance:
   Ensure that all assembly processes comply with relevant industry standards and regulations, particularly for medical-grade products.

Job Requirements:

• Bachelors degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
• A minimum of 5 years of experience in process engineering or assembly engineering, particularly within the plastic manufacturing industry.
• Expertise in molding and a strong background in medical plastics is a significant advantage.
• Proficiency in automation technologies and assembly process design.
• Fluent in Mandarin, both written and spoken, to communicate effectively with Mandarin-speaking stakeholders.
• Strong understanding of manufacturing processes, equipment, and quality control principles.