Assistant - QA Central (Customer Quality Support & Regulatory Compliance)

Join Hartalega, a global leader in manufacturing excellence, as our Assistant - QA Central (Customer Quality Support & Regulatory Compliance) in Bali, Indonesia. In this pivotal role, you will ensure our products meet the highest quality and regulatory standards, supporting our customers and maintaining our reputation for excellence.

As an Assistant - QA Central, you will be part of a dynamic team dedicated to quality assurance and regulatory compliance. You will work closely with our customers to understand their requirements and provide tailored solutions. Daily, you will conduct inspections, tests, and audits to ensure our products meet the strictest standards. This role offers a unique opportunity to grow and develop your skills in a fast-paced, innovative environment.

Based in our vibrant office in Canggu, Bali, you will have the chance to be part of a diverse and inclusive team. Hartalega is committed to fostering a culture of continuous improvement and innovation, providing you with the tools and support you need to thrive.

📋 Tanggung Jawab Pekerjaan

• Conduct inspections and tests to ensure products meet quality and regulatory standards.
• Collaborate with customers to understand their requirements and provide tailored solutions.
• Prepare and maintain comprehensive quality and compliance documentation.
• Perform root cause analysis and implement corrective actions to prevent recurrence of issues.
• Conduct internal and external audits to assess compliance with quality and regulatory standards.
• Provide training and guidance to staff on quality and compliance procedures.
• Monitor and report on quality and compliance metrics to senior management.
• Stay updated with industry trends and best practices in quality assurance and regulatory compliance.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Quality Assurance, Engineering, or a related field.
• Minimum 3 years of experience in quality assurance and regulatory compliance.
• Proficient in using quality management software such as SAP QM, IBM Quality Assurance, or similar.
• Certification in ISO 9001, ISO 13485, or other relevant quality and regulatory standards is a plus.
• Strong knowledge of regulatory requirements such as FDA, EU, or other international standards.
• Excellent communication and interpersonal skills.
• Ability to work in a fast-paced, dynamic environment.
• Fluent in English, both written and spoken.

🛠️ Keahlian

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