Medical Device Quality Engineer: CAPA & Audits

Jabil Circuit (Singapore) Pte Ltd; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Jabil Circuit (Singapore) Pte Ltd in Singapore seeks 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 ideal candidate will have strong knowledge of quality systems, risk management, and regulatory requirements such as ISO 13485, FDA QSR (21 CFR Part 820), and GMP, with hands-on CAPA, audits, and design controls experience.

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, ISO 14971 (Risk Management), and 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.

Responsibilities

• Support and maintain the Quality Management System (QMS) in compliance with ISO9001 & ISO 13485 and regulatory requirements.
• Lead and support CAPA investigations, root cause analysis, and effectiveness checks.
• Perform Internal Audits, Supplier Audits, and support external regulatory audits (FDA, notifi ed bodies).
• Review and approve design documentation (DHF, DMR, DHR).
• Participate in risk management activities (ISO 14971), including hazard analysis, FMEA, and risk control implementation.
• Collaborate with cross-functional teams for new product development and process validation.

Skills

ISO 13485

FDA 21 CFR Part 820

ISO 14971

GMP

CAPA

Audits

Root Cause Analysis

Validation

Documentation

Statistical Tools

Education

Bachelor’s degree in Engineering, Biomedical, Life Sciences

Tools

SPC

Six Sigma

IQ/OQ/PQ

Job description

Jabil Circuit (Singapore) Pte Ltd in Singapore seeks 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 ideal candidate will have strong knowledge of quality systems, risk management, and regulatory requirements such as ISO 13485, FDA QSR (21 CFR Part 820), and GMP, with hands-on CAPA, audits, and design controls experience.