Senior Product Quality Engineer, Life Sciences

amIT Global Solutions Sdn Bhd; Indonesia; On-site; IDR 180,000,000 - 320,000,000; Full time

Job summary

Esco Lifesciences Group, a Singapore headquartered, globally expanding life sciences company, is seeking a Product Quality Engineer to oversee quality from NPI to sustaining stages in Bintan, Indonesia. You will act as quality steward for assigned product families and collaborate with SQE and cross-functional teams to ensure robust QMS compliance.

The role emphasizes CAPA, 8D, ICH/GMP-like standards, and continuous improvement through Kaizen.

Qualifications

• Bachelor's degree in Electrical and Electronics Engineering.
• Minimum 5 years in Quality or Manufacturing Engineering.
• Strong knowledge of quality, reliability, and root cause analysis methods.
• Experience with ISO 9001, ISO 13485, ISO 14971 and related QMS.
• Ability to read 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.
• Participate in product validation & verification (V&V) activities and quality reviews.
• Lead investigations using 8D methodology for corrective actions.
• Monitor field performance data and drive customer quality improvement initiatives.
• 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 (CCR/CCI) and sustain improvements.
• Handle non-conformance issues and root cause analysis activities.
• Ensure compliance with ISO, MDR, and other QMS requirements.
• Support audits and present quality dashboards and analysis to management.

Skills

Quality engineering

Manufacturing engineering

Root cause analysis

Problem solving

Documentation discipline

Reading schematics/BOMs

Cross-functional collaboration

Education

Bachelor's degree in Electrical and Electronics Engineering

Job description

Esco Lifesciences Group, a Singapore headquartered, globally expanding life sciences company, is seeking a Product Quality Engineer to oversee quality from NPI to sustaining stages in Bintan, Indonesia. You will act as quality steward for assigned product families and collaborate with SQE and cross-functional teams to ensure robust QMS compliance.

The role emphasizes CAPA, 8D, ICH/GMP-like standards, and continuous improvement through Kaizen.