Medical Device Quality Engineer - QMS & CAPA Leader

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

Job summary

Jabil in Singapore seeks a detail-oriented Quality Engineer to ensure regulatory compliance and drive improvements in product quality and manufacturing processes. You will support QMS, CAPA, audits, and design/document control, collaborating with R&D, Manufacturing, and Regulatory Affairs.

The role requires 3–8 years in quality engineering within medical devices or healthcare, with strong knowledge of ISO 13485, FDA QSR, and GMP. Excellent problem-solving and communication skills are essential.

Qualifications

• Bachelor’s degree in Engineering, Biomedical, Life Sciences, or related field.
• 3–8 years of quality engineering experience in medical device/pharmaceutical/healthcare.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, GMP.
• Experience with CAPA, audits, validation, and document control.
• Familiarity with SPC, Six Sigma, and Root Cause Analysis.
• Excellent problem-solving and communication skills.

Responsibilities

• Support and maintain the QMS in compliance with ISO 13485.
• Lead CAPA investigations, root cause analysis, and effectiveness checks.
• Perform internal and supplier audits; support external regulatory audits.
• Review and approve design documentation (DHF/DMR/DHR); participate in risk management.
• Collaborate with cross-functional teams for new product development and validation.
• Ensure GMP compliance and manage non-conformances; drive continuous improvement.

Skills

Attention to detail

Analytical thinking

Cross-functional collaboration

Communication skills

Education

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

Tools

SPC

Six Sigma

GMP/QMS knowledge

Job description

Jabil in Singapore seeks a detail-oriented Quality Engineer to ensure regulatory compliance and drive improvements in product quality and manufacturing processes. You will support QMS, CAPA, audits, and design/document control, collaborating with R&D, Manufacturing, and Regulatory Affairs.

The role requires 3–8 years in quality engineering within medical devices or healthcare, with strong knowledge of ISO 13485, FDA QSR, and GMP. Excellent problem-solving and communication skills are essential.