Deskripsi pekerjaan
This role provides for end-to-end establishment, cost control, and as management of the Indonesian factory, driving efficiency production targets.
Tanggung jawab: 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 re; 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 efficie; 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 c; 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.
Kualifikasi: 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, CPB, CDB, 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.
Tanggung jawab
- 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 re
- 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 efficie
- 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 c
- 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
Kualifikasi
- 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, CPB, CDB, 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
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Gaji
- Negosiasi