Medical Device Quality Engineer - ISO 13485 & CAPA

Jabil; Singapore; Sur place; SGD 70 000 - 110 000; Plein temps

Résumé du poste

Jabil in Singapore is seeking a detail-oriented Quality Engineer with experience in the medical device industry to ensure regulatory compliance and drive continuous improvement in product quality and manufacturing processes.

The ideal candidate will have an engineering degree and hands-on experience with ISO 13485, FDA QSR (21 CFR Part 820), GMP, CAPA, audits, risk management, and design documentation such as DHF/DMR/DHR, enabling effective cross-functional collaboration across R&D,

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

Responsabilités

• Maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements.
• Lead CAPA investigations, root cause analysis, and effectiveness checks.

Connaissances

CAPA investigations

Audits

Statistical tools

Root Cause Analysis

Quality systems

Problem solving

Communication skills

Formation

Bachelor’s degree in Engineering, Biomedical, Life Sciences

Outils

IQ/OQ/PQ validation

QMS software

Design history file

Description du poste

Jabil in Singapore is seeking a detail-oriented Quality Engineer with experience in the medical device industry to ensure regulatory compliance and drive continuous improvement in product quality and manufacturing processes.

The ideal candidate will have an engineering degree and hands-on experience with ISO 13485, FDA QSR (21 CFR Part 820), GMP, CAPA, audits, risk management, and design documentation such as DHF/DMR/DHR, enabling effective cross-functional collaboration across R&D,