Key Responsibilities:

Factory Establishment & Strategic Planning: Oversee all preparatory activities for the Indonesian factory prior to production, including location assessment, project licensing, and coordination with relevant government bodies. Build and maintain strong relationships with government authorities to ensure compliance, smooth approvals, and long-term operational stability. Lead the creation of strategic production and operational plans covering capacity, workforce allocation, budget, and long-term growth objectives.
Financial & Cost Management: Manage and monitor production expenses, including raw materials, manpower, and utilities. Implement efficiency improvements to control costs while sustaining product quality and operational performance.
Production Oversight: Develop and execute annual production targets and operational strategies to ensure timely delivery. Monitor shop-floor operations through regular inspections, provide guidance, and manage production workflows to maintain high efficiency and meet quality benchmarks.
Quality Assurance & Compliance: Ensure products meet ISO 13485, CPAKB, CDAKB, and internal quality requirements. Conduct periodic audits, address non-conformities, and maintain alignment with both company and regulatory standards.
Supply Chain & Procurement Management: Select and evaluate reliable suppliers, establish long-term partnerships, and secure timely raw material supply. Oversee inventory management and optimize logistics processes to reduce lead times and costs.
Regulatory Registration & Certification: Oversee preparation and submission of technical documentation to meet Indonesian Ministry of Health, FDA, EU MDR, and other applicable regulatory requirements. Ensure timely completion of product registration and certification.
Systems & Policy Implementation: Develop and enhance management systems for the Indonesian factory. Establish employee evaluation criteria, reward systems, and enforce policies to ensure consistent application across the organization.
Management Representative Responsibilities: - Ensure all processes required for the quality management system are defined, implemented, and maintained.

Requirements / Qualifications:

Bachelor's degree or higher in Engineering, Manufacturing, Business Administration, or related fields.
Minimum over 5 years experience in manufacturing management, with at least 3 years in a senior leadership position.
Proven experience in managing large-scale production facilities, preferably in the medical device or regulated manufacturing sector.
Strong understanding of ISO 13485, CPAKB, CDAKB, TKDN, and regulatory compliance requirements.
Demonstrated ability to build and maintain positive relationships with government agencies and regulatory authorities.
Excellent leadership, communication, and problem-solving skills.
Fluent in Bahasa Indonesia and English is a must; Mandarin proficiency is an advantage.

Plant General Manager (Indonesia Base)