Product Quality Engineer - NPI to Sustainment

Esco; Indonesia; On-site; IDR 1,070,473,000 - 2,140,946,000; Full time

Job summary

Esco Lifesciences Group is a global leader in life science tools, diagnostics, and technologies. The Product Quality Engineer will steer quality across product families from NPI to sustaining, maintaining DHF/DMR, and driving V&V activities to ensure regulatory compliance.

You will lead investigations using 8D, manage quality plans, and collaborate with cross-functional teams to improve field performance and supplier quality. A strong foundation in ISO/QMS and problem-solving is essential.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Electrical, Electronics, Biomedical, Industrial, Chemical, or related fields).
• Minimum 5 years of experience in Quality Engineering or Manufacturing Engineering.
• Strong knowledge of quality, reliability, and root cause analysis methods (5 Why, Ishikawa, Fault Tree Analysis).
• Familiar with ISO 9001, ISO 13485, ISO 14971 and related QMS.
• Understanding of electronics boards, sensors, PCBAs, and mechanical assemblies.
• Knowledge of CAPA, 8D, control plans, and non-conformance handling.
• Strong problem-solving, analytical, and troubleshooting skills.
• Reading engineering drawings, schematics, and BOMs.

Responsibilities

• Act as quality steward for assigned product families from NPI to sustaining.
• Manage DHF/DMR documentation and ensure regulatory compliance with standards.
• Lead in product validation & verification (V&V) activities and quality reviews.
• Maintain Product Quality Plans, SOPs, work instructions, and inspection standards.
• Lead/customer complaint investigations and corrective actions using 8D methodology.
• Monitor field performance data and drive customer quality improvement initiatives.
• Support production quality improvement activities, including Kaizen and FPY improvement.
• Collaborate with SQE to monitor supplier quality and improvement effectiveness.
• Evaluate quality impact of engineering changes (CCR/CCI) and support sustaining improvements.
• Handle non-conformance issues and support root cause analysis activities.
• Ensure compliance with ISO, MDR, and other applicable QMS.
• Support audits, maintain audit readiness, and present quality dashboards to management.

Skills

Quality engineering

Root cause analysis

Documentation

Regulatory compliance

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Job description

Esco Lifesciences Group is a global leader in life science tools, diagnostics, and technologies. The Product Quality Engineer will steer quality across product families from NPI to sustaining, maintaining DHF/DMR, and driving V&V activities to ensure regulatory compliance.

You will lead investigations using 8D, manage quality plans, and collaborate with cross-functional teams to improve field performance and supplier quality. A strong foundation in ISO/QMS and problem-solving is essential.