Product Quality Engineer

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 improving lives through science! Headquartered in Singapore, expanded globally with factories and offices in 43 locations around the world, Esco is building a synergistic ecosystem of life science tools, diagnostics, therapies, and technologies to improve human lives.

With nearly 50 years of history and a strong foundation in Singapore, Esco is a dynamic, fast-growing, mid-sized multinational organization that bridges East and West. We offer a diverse, inclusive, and globally connected environment where you’ll collaborate with top experts and visionary clients worldwide. As we accelerate our global expansion, you’ll have the unique opportunity to grow your career in tandem with the company, driving innovation and shaping a healthier, more equitable, and resilient future.

Job Title: Product Quality Engineer

Direct Manager: Quality Manager

Key Responsibilities:

• Act as quality steward for assigned product families from NPI to sustaining stage
• Manage DHF/DMR documentation and ensure compliance with regulatory and product standards
• Participate in product validation & verification (V&V) activities and quality reviews
• Maintain Product Quality Plans, SOPs, work instructions, and inspection standards
• Lead/support 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 Quality Management Systems (QMS)
• Support audits, maintain audit readiness, and present quality performance dashboards and analysis to management

Key Requirements:

• 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 product quality, reliability, and root cause analysis methods (5 Why, Ishikawa, Fault Tree Analysis)
• Familiar with ISO 9001, ISO 13485, ISO 14971, and related Quality Management Systems
• Understanding of electronics boards, sensors, PCBA quality, and mechanical assemblies
• Knowledge of CAPA, 8D methodology, control plans, and non-conformance handling
• Strong problem-solving, analytical, and troubleshooting skills
• Ability to read and interpret engineering drawings, schematics, and BOMs
• Experience in supplier quality evaluation and material quality assessment
• Strong communication and cross-functional collaboration skills with technical and non-technical teams
• Disciplined in documentation and capable of leading quality investigations and improvement activities
• Preferred certifications: CQE, Six Sigma Green Belt (or above), and ISO 9001/ISO 13485 Internal Auditor certification