Quality Control (Medical Device)

CGBio Korea; Hegarmukti; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A global medical device organization is seeking a Quality Control team member in Indonesia. This role involves supporting quality management systems, conducting QC testing, and ensuring compliance with regulatory standards such as ISO 13485 and GMP. The candidate will initially work in Korea for training for 1–1.5 years before transitioning to the new manufacturing plant in Indonesia. Strong time management skills and a detail-oriented mindset are crucial for success in this position. Certification as a Chemical Analysis Engineer is preferred.

Qualifications

• Ability to work efficiently and deliver results.
• Basic understanding of medical device testing methods.
• Knowledge of ISO 13485 and GMP standards.

Responsibilities

• Assist in building and maintaining the medical device quality system.
• Support compliance with regulatory and quality requirements.
• Conduct QC testing for raw materials and finished products.
• Participate in routine inspections and documentation.

Skills

Time management

Understanding of medical device testing

Quality control procedures

Detail-oriented

Foreign language skills (English)

Education

Chemical Analysis Engineer certification

Job description

The Indonesia TF Quality Control Team at CGBio plays a critical role in supporting the company’s core businesses, including medical device and cosmetics manufacturing.

This team is responsible for building and operating quality control systems aligned with global standards. The knowledge and experience gained will later be transferred and applied to CGBio’s future manufacturing facility in Indonesia, supporting long-term business expansion and localization.

Joining this team provides hands‑on exposure to a comprehensive quality system within a global medical device organization.

Key Responsibilities

Quality Management System (QMS) Support

• Assist in building, maintaining, and operating the medical device quality system
• Support compliance with regulatory and quality requirements to ensure on‑time product release
• Participate in quality documentation management and system improvement activities

Quality Control & Testing

Conduct QC testing for:

• Raw materials and packaging materials
• Finished products
• Microbiological testing

Support routine inspections, sampling, and test result documentation.

Regulatory & Compliance Support

• Perform testing and quality activities in compliance with: ISO 13485 and GMP standards.
• Assist during audits, inspections, and internal quality reviews.

Qualifications

Required Qualifications

Strong time management skills with the ability to work efficiently and deliver results.

Basic understanding of:

• Medical device testing methods
• Quality control procedures and laboratory work

Knowledge of medical device quality systems such as:

• ISO 13485
• GMP

Detail‑oriented, responsible, and eager to learn in a regulated environment.

Preferred Qualifications

• Chemical Analysis Engineer certification
• Strong foreign language skills, especially English.

Training & Development Vision

The selected candidate will initially work in Korea and receive on‑the‑job training for approximately 1–1.5 years, before being assigned to the new Indonesia manufacturing plant scheduled for completion in Q2 2027.

At CG Bio Indonesia, we combine medical science and beauty to deliver advanced solutions. Our products include HA fillers, bone grafts, anti‑adhesion agents, and foam dressings. We support Indonesian doctors through training and collaboration to ensure better outcomes. To boost local innovation, we’re building the CGMedTech Innovation Campus in Cikarang to produce 500,000 HA fillers monthly. Alongside this, our NuLook Clinic offers premium K‑Aesthetic treatments and medical training — setting new standards in beauty and care.