Factory Head

PT HUGE DENTAL INDONESIA; Tangerang; On-site; IDR 450,000,000 - 600,000,000; Full time

Job summary

PT HUGE DENTAL INDONESIA is seeking a senior Manufacturing Manager to oversee Indonesian factory preparations, licensing, and government coordination before production.

You will lead strategic production plans, manage budgets and capacity, and ensure compliance with ISO 13485 and regulatory standards while building strong government relationships.

Qualifications

• Bachelor's degree or higher in Engineering, Manufacturing, Business Administration, or related fields.
• Minimum 5 years' experience in manufacturing management.
• At least 3 years in a senior leadership position.
• Experience in medical device or regulated manufacturing.
• Fluent in Bahasa Indonesia and English; Mandarin proficiency is an advantage.

Responsibilities

• Oversee preparatory activities for the Indonesian factory prior to production.
• Coordinate with government bodies for licensing and approvals.
• Lead strategic production and operational planning (capacity, budget, growth).
• Manage production expenses including raw materials, manpower, utilities.
• Develop annual production targets and operational strategies.
• Monitor shop-floor operations and ensure high efficiency and quality.
• Ensure products meet ISO 13485, CPAKB, CDAKB and internal quality requirements.
• Oversee supplier selection and long-term partnerships for materials supply.
• Prepare and submit technical documentation for regulatory compliance.
• Develop and enhance management systems for the factory.

Skills

Leadership

Communication

Problem-solving

Regulatory compliance

ISO 13485 knowledge

Education

Bachelor's degree in Engineering

Job description

Oversee all preparatory activities for the Indonesian factory prior to production, including location assessment, project licensing, and coordination with relevant government bodies. Lead the creation of strategic production and operational plans covering capacity, workforce allocation, budget, and long-term growth objectives.

Key responsibilities

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

Manage and monitor production expenses, including raw materials, manpower, and utilities

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

Ensure products meet ISO 13485, CPAKB, CDAKB, and internal quality requirements

Select and evaluate reliable suppliers, establish long-term partnerships, and secure timely raw material supply

Oversee preparation and submission of technical documentation to meet Indonesian Ministry of Health, FDA, EU MDR, and other applicable regulatory requirements

Develop and enhance management systems for the Indonesian factory

About you

Bachelor's degree or higher in Engineering, Manufacturing, Business Administration, or related fields

Minimum 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