QA/QC Engineer – Quality Management System

Pengiklan Anonim; Krian; On-site; IDR 78,120,000 - 133,920,000; Full time

Job summary

PT Zenith Allmart Precisindo is seeking a QA/QC Engineer with experience in QA/QC within the medical device or electromedical industry. The role focuses on ensuring product quality, process control, and developing QMS documentation in line with medical industry standards.

You will conduct inspections, support internal and supplier audits, manage NCR/CAPA, and perform root cause analyses while collaborating with Production, Engineering, and QC teams to drive continuous improvement.

Qualifications

• Minimum S1/D4 in Engineering or Physics/Material Chemistry.
• Minimum 2 years in the medical device/electromedical industry.
• Experience implementing QMS, such as procedure development, document control, audit preparation, or certification audits.
• Understanding ISO 13485:2016; knowledge of ISO 9001:2015 is an advantage.
• Reading technical drawings; proficiency with measuring instruments.
• Proficient in Excel for quality data processing and analysis.
• Passive English language ability for reading standards and procedures.

Responsibilities

• Conduct inspection and quality control of incoming material, production processes, and final products.
• Ensure 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 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.

Skills

Quality management

Root Cause Analysis

NCR/CAPA handling

5 Why/Fishbone

Reading technical drawings

Excel data analysis

Cross-functional collaboration

Documentation

Education

S1/D4 in Engineering (Mechanical, Material/Metallurgy, Industrial, Electrical, Biomedical) or Physics/Material Chemistry

Tools

Microsoft Excel

Caliper

Micrometer

Height gauge

Calibration documentation tools

Job description

QA/QC Engineer – Quality Management System

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