QA/QC Quality Section Leader — Medical Devices

PT Oneject Indonesia; Desa Ciranjeng; On-site; IDR 260,000,000 - 420,000,000; Full time

Job summary

PT Oneject Indonesia, a leading medical devices manufacturer of Auto Disable Syringes, is seeking a QA/QC Leader to drive quality assurance and regulatory compliance. The role requires a strong background in QMS, CAPA, audits, and documentation, with English proficiency and team leadership.

The position is based in KITIC Cikarang, Indonesia. The ideal candidate will have 3+ years in QA/QC or 1+ year as Quality Section Head in a medical device setting, and will manage documentation,

Qualifications

• Bachelor Degree in Pharmacy, Chemical, or Industrial Engineering.
• Minimum 3 years QA/QC experience or 1+ year as Quality Section Head in medical devices.
• Strong knowledge of QMS and regulatory standards; ISO 9001 and ISO 13485 familiarity.
• Excellent English communication, both written and spoken.
• Ability to lead a team, assign tasks, monitor performance and ensure procedure compliance.
• Willing to be stationed at KITIC Cikarang; based in Indonesia.

Responsibilities

• Lead the QA/QC department to ensure product quality and regulatory compliance.
• Maintain and update documentation related to compliance, CAPA, Change Control, and audits.
• Review circulating documents; monitor documentation systems; establish SOPs/WIs.
• Provide investigation reports and oversee quality control testing and analysis.
• Ensure GMP/ISO compliance across all manufacturing and QC activities.

Skills

QA/QC

CAPA

Audit

Documentation

ISO 9001

ISO 13485

Leadership

English

Education

Bachelor Degree in Pharmacy / Chemical / Industrial Engineering

Tools

Laboratory testing

Job description

PT Oneject Indonesia, a leading medical devices manufacturer of Auto Disable Syringes, is seeking a QA/QC Leader to drive quality assurance and regulatory compliance. The role requires a strong background in QMS, CAPA, audits, and documentation, with English proficiency and team leadership.

The position is based in KITIC Cikarang, Indonesia. The ideal candidate will have 3+ years in QA/QC or 1+ year as Quality Section Head in a medical device setting, and will manage documentation,