Quality Engineer – Medical Devices & Regulatory Compliance

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

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.