Regulatory Affairs jobs in Malaysia

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.

1. QMS Development & Maintenance:
   • Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and other relevant ISO standards.
   • Ensure all QMS documentation, including policies, procedures, and work instructions, are up-to-date and effectively implemented.
2. Medical Plastics & Molding Expertise:
   • Utilize your expertise in medical plastics to ensure that all products are manufactured in compliance with industry standards and regulatory requirements.
   • Oversee the quality aspects of the molding process to ensure consistency and reliability in product quality.
3. ISO Compliance & Certification:
   • Lead efforts to achieve and maintain ISO 13485 certification, and ensure compliance with other relevant ISO standards for medical products.
   • Conduct internal audits to assess compliance and identify areas for improvement.
   • Drive continuous improvement initiatives within the QMS to enhance product quality, reduce defects, and increase efficiency.
   • Collaborate with production, engineering, and quality teams to implement corrective and preventive actions (CAPAs).
4. Regulatory & Customer Compliance:
   • Ensure all products meet regulatory requirements and customer specifications, especially for medical devices.
   • Liaise with regulatory bodies and customers during audits and inspections.
5. Training & Support:
   • Provide training to employees on QMS processes, ISO standards, and quality topics.
   • Foster a culture of quality and compliance across the organization.
6. Documentation & Reporting:
   • Maintain detailed records of all quality activities, including audit reports, non-conformances, and CAPAs.
   • Prepare reports on QMS performance, highlighting key metrics and improvement areas.
   • Assess risks related to product quality and compliance, and develop mitigation strategies.
   • Implement risk management processes in line with ISO standards.

• Bachelor's degree in Quality Engineering, Mechanical Engineering, Manufacturing Engineering, or related field.
• At least 5 years of experience in quality management within molding and plastic manufacturing industries.
• Expertise in medical plastics is a significant advantage.
• Strong knowledge of ISO 13485 and other relevant ISO standards (e.g., ISO 14971, ISO 9001).
• Fluent in Mandarin, both written and spoken, to communicate effectively with Mandarin-speaking stakeholders.