Product Quality Engineer - Life Sciences Tools

PT Esco Bintan Indonesia; Kepulauan Riau; On-site; IDR 180,000,000 - 260,000,000; Full time

Job summary

Esco Lifesciences Group, with its Indonesia manufacturing hub in Bintan, seeks a Product Quality Engineer to oversee quality across product families from NPI to sustainment. You will manage DHF/DMR, participate in V&V activities, and lead investigations to ensure regulatory compliance of electronics and assemblies.

You will collaborate with SQE, production, and engineering to maintain quality plans, CAPA processes, and continuous improvement, while supporting audits and dashboards.

Qualifications

• Bachelor's degree in Engineering, mainly in Electrical and Electronics.
• Minimum 5 years of experience in Quality or Manufacturing Engineering.
• Strong knowledge of product quality, reliability, and root cause methods (5 Why, Ishikawa, FTA).
• Familiar with ISO 9001, 13485, 14971 and related QMS.
• Understanding of electronics boards, sensors, PCBA quality, and mechanical assemblies.
• Knowledge of CAPA, 8D, control plans, and non-conformance handling.
• Strong problem-solving, analytical and troubleshooting skills.
• Ability to read engineering drawings, schematics, and BOMs.
• Experience in supplier quality evaluation and material quality assessment.
• Strong communication and cross-functional collaboration skills.
• Disciplined documentation and leadership in quality investigations.
• Preferred: CQE, Six Sigma Green Belt or higher, ISO 9001/13485 Internal Auditor.

Responsibilities

• Act as quality steward for assigned product families from NPI to sustaining stage.
• Manage DHF/DMR documentation and ensure regulatory compliance.
• Participate in product validation and verification activities and quality reviews.
• Maintain Product Quality Plans, SOPs, work instructions, and inspection standards.
• Lead/support customer complaint investigations using 8D methodology.
• Monitor field performance data and drive customer quality improvements.
• Support production quality improvement activities including Kaizen and FPY.
• Collaborate with SQE to monitor supplier quality and improvement effectiveness.
• Evaluate quality impact of engineering changes and sustain improvements.
• Handle non-conformance issues and support root cause analysis.

Skills

Quality engineering

Manufacturing engineering

Root cause analysis

8D methodology

CAPA

ISO 9001/13485

Electronics / PCBA quality

Reading drawings & BOMs

Cross-functional collaboration

Analytical problem solving

Education

Bachelor’s degree in Engineering (Electrical/Electronics)

Job description

Esco Lifesciences Group, with its Indonesia manufacturing hub in Bintan, seeks a Product Quality Engineer to oversee quality across product families from NPI to sustainment. You will manage DHF/DMR, participate in V&V activities, and lead investigations to ensure regulatory compliance of electronics and assemblies.

You will collaborate with SQE, production, and engineering to maintain quality plans, CAPA processes, and continuous improvement, while supporting audits and dashboards.