QA Assistant Manager – ISO 13485 Medical Devices

PT Medira Mega Investco; Depok; On-site; IDR 180,000,000 - 300,000,000; Full time

Job summary

PT Medira Mega Investco in Depok, West Java, seeks an Assistant Quality Assurance Manager to lead QA/QC activities under ISO 13485 and GMP for medical devices. The role requires a strong background in QMS documentation, risk management, and internal/external auditing.

You will oversee SOPs, WI, and quality records, ensure traceability, drive continual improvement, and mentor a small QA team. Proficiency in English and solid leadership are essential for success in this position.

Qualifications

• Bachelor's degree in Pharmacy, Biomedical Engineering, Industrial Engineering, Chemical Engineering or related fields.
• Minimum 5 years of experience in Quality Assurance within the medical device, pharmaceutical, or other regulated manufacturing industries, including at least 3 years in a supervisory or assistant managerial role.
• Understanding of ISO 13485:2016 - Medical Device or Good Manufacturing Practices for Medical Devices (GMPMD) and applicable Indonesian medical device regulations.
• Knowledge of Risk Management is an advantage.
• Good understanding of GDP and Quality Management System documentation requirements.
• Experience in preparing, reviewing, revising, and maintaining QMS documentation, including Quality Manuals, SOPs, WI, and quality records.
• Proficient in English communication, both spoken and written.
• Leadership, analytical, attention to detail, and good team coordination skills.
• Strong character: hardworking, adaptable, committed, dedicated, and high integrity.
• Willing to be placed at Depok – West Java.

Responsibilities

• Ensuring Good Manufacturing Practices and Quality Management System based on ISO 13485:2016 and GMP for Medical Devices (GMPMD) requirements are performed properly and correctly.
• Manage overall QA & QC activities, create the system and procedures, and ensure that all processes and products meet the requirements or specified standard.
• Ensuring activities of material and product testing and activities in the laboratory are performed in accordance with principle of Good Laboratory Practices.
• Acting as an Internal Auditor and External Auditor.
• Reviewing and/or approving SOP, WI, and other documents related to Company's quality management system.
• Ensuring documentation management system in the Company is performed in accordance with procedures
• Reviewing/approving of change control related to quality management system in the Company.
• Preparing quality objectives and targets for QA & QC Department and review targets proposed by each department.
• Reviewing and/or approving protocol and report of machine, equipment qualification and process validation
• Ensuring every procedures/record can be identified and traceable
• Ensuring any non-conformities are documented and handled in accordance with procedures
• Handling of feedback and customer complaint, product recall, returned product handling and product rework in accordance with the procedure
• Approving documents related to internal audit and supplier audit.
• Approving that any corrections, corrective actions and preventive actions taken by each department
• Determining the product disposition status
• Ensuring the handling of material and process status labels are performed properly.
• Approving protocol and report of the product stability study.
• Ensuring the availability of retained product sample
• Reviewing the risk assessment report of each department and ensuring risk controls are performed by each department.
• Evaluating production results regularly
• Reviewing and approving registration and permission document of the medical devices.

Skills

QA in regulated industry

Leadership

English proficiency

Analytical thinking

Detail-oriented

Team coordination

Depok placement

Education

Bachelor's degree in Pharmacy, Biomedical Engineering, Industrial Engineering, Chemical Engineering or related fields

Job description

PT Medira Mega Investco in Depok, West Java, seeks an Assistant Quality Assurance Manager to lead QA/QC activities under ISO 13485 and GMP for medical devices. The role requires a strong background in QMS documentation, risk management, and internal/external auditing.

You will oversee SOPs, WI, and quality records, ensure traceability, drive continual improvement, and mentor a small QA team. Proficiency in English and solid leadership are essential for success in this position.