QA/QC Engineer – Quality Management System

About the role

PT Zenith Allmart Precisindo is seeking a QA/QC Engineer with experience in Quality Assurance/Quality Control in the medical device or electromedical industry. This role plays an important part in ensuring product quality, process control, and the implementation and development of Quality Management System (QMS) in accordance with medical device industry standards.

Key responsibilities

• Conduct inspection and quality control of incoming material, production processes, and final products
• Ensure production processes and products meet specifications, standards, and customer requirements
• Develop, update, and control Quality Management System documentation
• Prepare documents and data for internal audits, customer audits, and certification audits
• Handle Non-Conformity (NCR), CAPA, and customer complaints
• Perform Root Cause Analysis using methods such as 5 Why and Fishbone
• Manage calibration programs for measuring instruments and support laboratory testing
• Process and analyse quality data using Microsoft Excel
• Support implementation of Risk Management, FMEA, Control Plan, SPC, and continuous improvement
• Collaborate with Production, Engineering, QC, and Innovation Team in new product development

About you

• Minimum S1/D4 education in Engineering (Mechanical, Material/Metallurgy, Industrial, Electrical, Biomedical) or Physics/Material Chemistry
• Minimum 2 years of experience in the medical device, medical device, or electromedical industry
• Experience in implementing Quality Management System, such as procedure development, document control, audit preparation, or certification audit support
• Understanding and experience in implementing ISO 13485:2016
• Understanding of ISO 9001:2015 is an advantage
• Understanding of Quality Assurance & Quality Control processes in industries with strict requirements/regulations
• Able to read technical drawings
• Proficient with basic measuring instruments such as caliper, micrometer, and height gauge
• Understanding of NCR, CAPA, Root Cause Analysis, 5 Why, and Fishbone
• Able to develop procedures, reports, and quality documentation systematically
• Proficient in Microsoft Excel for quality data processing and analysis
• Minimum passive English language ability, particularly for reading standards, regulations, procedures, and technical documents