Quality Engineer (Medical Devices)

Jabil Circuit Sdn Bhd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Jabil Circuit Sdn Bhd is seeking a detail-oriented Quality Engineer with experience in the medical device or healthcare products industry to ensure regulatory compliance and drive continuous improvement in quality and manufacturing processes.

The role focuses on maintaining QMS (ISO 13485), leading CAPAs, audits, design documentation reviews, and risk management activities to support new product development and process validation.

Qualifications

• Bachelor's degree in Engineering, Biomedical, Life Sciences or related field.
• 3–8 years of experience in quality engineering within medical device/healthcare industries.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820) and GMP requirements.

Responsibilities

• Support and maintain QMS in compliance with ISO 13485 and regulatory requirements.
• Lead and support CAPA investigations, root cause analysis, and effectiveness checks.
• Perform internal and supplier audits and support external regulatory audits.
• Review and approve design documentation (DHF/DMR/DHR).
• Participate in risk management activities (ISO 14971) including FMEA.
• Collaborate with cross-functional teams for new product development and validation.
• Ensure GMP compliance and handle non-conformances (NCR).
• Support validation activities (IQ/OQ/PQ, software, process).
• Drive supplier quality management and continuous improvement initiatives.
• Analyze quality data and lead Lean/Six Sigma projects.

Skills

Quality Systems

Risk Management

CAPA

Audits

QMS

FMEA

Regulatory knowledge

Education

Bachelor's in Engineering

Tools

SPC

Job description

The ideal candidate will have strong knowledge of quality systems, risk management, anWe are seeking a detail-oriented Quality Engineer with experience in the medical device or healthcare products industry to ensure compliance with regulatory standards and drive continuous improvement in product quality and manufacturing processes. d regulatory requirements such as ISO 13485, FDA QSR (21 CFR Part 820), and GMP.

Key Responsibilities

Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements.

Lead and support CAPA (Corrective and Preventive Actions) investigations, root cause analysis, and effectiveness checks.

Perform Internal Audits, Supplier Audits, and support external regulatory audits (FDA, notified bodies).

Review and approve design documentation, including DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record).

Participate in risk management activities (ISO 14971), including hazard analysis, FMEA, and risk control implementation.

Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) for new product development and process validation.

Ensure compliance with Good Manufacturing Practices (GMP) and quality standards.

Handle non-conformance reports (NCR) and lead investigations for product or process deviations.

Support validation activities (IQ/OQ/PQ, software validation, process validation).

Drive supplier quality management, including qualification, monitoring, and performance evaluation.

Analyze quality data and implement continuous improvement initiatives (Lean, Six Sigma).

Required Qualifications

Bachelor’s degree in Engineering, Biomedical, Life Sciences, or related field.

3–8 years of experience in quality engineering within the medical device/pharmaceutical/healthcare industry.

Strong working knowledge of:

ISO 13485

FDA 21 CFR Part 820

GMP requirements

Experience with CAPA, audits, validation, and document control systems.

Familiarity with statistical tools and quality methodologies (SPC, Six Sigma, Root Cause Analysis).

Excellent problem-solving, analytical, and communication skills.

Preferred Qualifications

Certification such as Certified Quality Engineer (CQE) or Six Sigma Green Belt/Black Belt will added advantage

Experience with sterile products, combination products, or Class II/III medical devices.

Knowledge of regulatory submissions (e.g., 510(k), CE Marking).

Experience with electronic QMS systems

Experience in supplier quality management.

Experience in HLA (and High Level Assembly Manufacturing) SMT (PCBA manufacturing)

Attention to detail and compliance mindset

Strong analytical and investigative skills

Cross-functional collaboration

Effective communication and documentation

Office and manufacturing floor interaction

May require participation in audits, inspections, and supplier visits

Example KPIs

CAPA closure timelines

Audit findings and compliance scores

Reduction in non-conformances

Process improvement metrics

Supplier quality performance