Product Quality Engineer

Esco; Kepulauan Riau; On-site; IDR 668.672.000 - 1.003.010.000; Full time

Job summary

A global life sciences company seeks a Product Quality Engineer to manage product quality and compliance. The role involves leading quality initiatives, supporting investigations, and ensuring adherence to relevant standards. Candidates should possess a Bachelor's degree in Engineering and have at least 2-3 years of experience in quality or manufacturing engineering. Strong skills in problem-solving, communication, and documentation are essential. Join this fast-growing multinational organization in enhancing lives through science.

Qualifications

• Minimum 2-3 years’ experience in quality engineering or manufacturing engineering.
• Core Technical Knowledge in Product & Reliability including Root Cause Analysis.
• Ability to read engineering drawings and BOM.

Responsibilities

• Act as the quality steward for assigned product families.
• Lead or support 8D investigations for customer complaints.
• Ensure products comply with ISO and MDR or similar QMS.

Skills

Problem-solving

Root Cause Analysis

Clear communication

Documentation discipline

Quality control practices

Education

Bachelor’s degree in Engineering

Tools

ISO 9001

ISO 13485

ISO 14971

CAPA methodology

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.

Product Quality Engineer

Location: Bintan, Indonesia

Direct Manager: Quality Manager

Key Responsibilities

A. Product Quality Management

• Act as the quality steward for assigned product families (from NPI to sustaining).
• DHF and DMR file management in design, development and transfer process.
• Manage the regulations and product standards of the target market, such as national and regional standards and industry standards, and implement them into product requirements.
• Participate in product v&v and serve as one of the reviewers.
• Maintain and update Product Quality Plans and inspection standards.
• Ensure all quality requirements (internal, regulatory, customer) are met before release.
• Outcome: Product is compliant, robust, and stable in field performance.

B. Customer Quality Improvement

• Lead or support 8D investigations for trending and critical customer complaints.
• Coordinate with Technical Support, Service, BU, R&D, and Manufacturing on root cause and corrective actions.
• Track field performance data in coordination with technical supports and drive defect rate reduction.
• Outcome: Lower complaint rate, higher customer satisfaction, stronger brand trust.

C. Production Quality Improvement

• Run or support Kaizen activities in the quality area.
• Drive and support reduction in FPY improvement.
• Promote a quality‑first culture within production teams.
• Outcome: Year‑on‑year improvement in quality KPIs.

D. Supplier quality improvement

• Work together with SQE to monitor the incoming quality of supplier.
• Track the effectiveness of improvement items from supplier.

E. Engineering Change & Sustaining Improvements

• Evaluate the quality impact of CCR/CCI.
• Support design improvements to address reliability, manufacturability, and cost issues.
• Participate in cross‑functional problem‑solving (Design, Manufacturing, Supply Chain).
• Outcome: Improved robustness, easier manufacturing, lower cost‑to‑serve.

F. Quality Control

• Understanding of validation (IQ/OQ/PQ)
• Ability to create and revise SOPs, WI, and QC inspection standards
• Experience in non‑conformance handling

G. Quality System Management

• Ensure products comply with ISO and MDR or other similar QMS.
• Maintain and review quality documentation, traceability, and audit readiness.
• Support internal/external audits and regulatory inspections.
• Analyse data from Field Issues and warranty claims together with Technical Support.
• Present monthly quality dashboards to Quality Manager.
• Identify top drivers and key initiatives.
• Outcome: Zero major findings, strong regulatory confidence, Data‑driven decisions; transparency across BU, region, and plant.

Key Requirements

1. Bachelor’s degree in Engineering (Mechanical, Electrical, Electronics, Biomedical, Industrial, Chemical).
2. Minimum 2-3 years’ experience in quality engineering or manufacturing engineering.
3. Core Technical Knowledge in Product & Reliability Knowledge, including Root Cause Analysis (5 Why, Ishikawa, Fault Tree), ISO 9001, ISO 13485 (Medical Devices), ISO 14971 (risk management), Understanding of Electronics Boards, sensors, PCBA quality, Mechanical assemblies.
4. Understanding of Methods in CAPA & 8D Methodology and Control Plans.
5. Strong problem‑solving and troubleshooting capability.
6. bility to read engineering drawings, schematics, and BOM.
7. Ability to evaluate supplier quality and materials.
8. Clear communication with both technical and non‑technical teams.
9. Strong documentation discipline and lead cross‑functional investigations (8D teams).
10. Ability to train inspectors/operators on quality requirements.
11. Certifications (Preferred but not required).

• CQE (Certified Quality Engineer) – ASQ
• Six Sigma Green Belt or higher
• Auditor certification: ISO 9001 or ISO 13485 Internal Auditor