Product Quality Engineer

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 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, mainly in Electrical and Electronics

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

Unlock job insights

Hirer responsiveness Salary match Number of applicants

Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees

Esco Lifesciences, founded in 1978, is a global leader in life science tools, driving innovation in Scientific, Healthcare, and Medical business units. We tackle modern challenges by delivering advanced equipment and services that support research, quality control, healthcare, and IVF solutions.

With our global headquarters in Singapore, Esco operates in over 100 countries, supported by 21 direct sales offices and 8 manufacturing and R&D centers worldwide. Esco Bintan in Indonesia plays a vital role as a key manufacturing hub. Trusted by world-renowned institutions like Harvard, Pfizer, GSK, and Stanford, Esco is committed to shaping the future of life sciences.

Esco Lifesciences, founded in 1978, is a global leader in life science tools, driving innovation in Scientific, Healthcare, and Medical business units. We tackle modern challenges by delivering advanced equipment and services that support research, quality control, healthcare, and IVF solutions.

With our global headquarters in Singapore, Esco operates in over 100 countries, supported by 21 direct sales offices and 8 manufacturing and R&D centers worldwide. Esco Bintan in Indonesia plays a vital role as a key manufacturing hub. Trusted by world-renowned institutions like Harvard, Pfizer, GSK, and Stanford, Esco is committed to shaping the future of life sciences.

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