MedTech Quality Engineer: Verification, QA & Compliance

Uromedtech Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

UroMedTech is seeking a detail-oriented Quality Engineer to drive excellence in Operational QC and Design Verification for medical devices and sterile kits. You will safeguard product safety and ensure compliance with international standards and our QMS.

You will manage IQC, final verification, calibration, and non-conformances, while contributing to risk management activities and maintaining the DHF as required by ISO 13485 and FDA guidelines.

Qualifications

• Bachelor’s or Diploma in Biomedical, Mechanical, or Mechatronics Engineering.
• Experience with regulated environments is a plus.
• Strong problem-solving and clear communication of technical findings.

Responsibilities

• Manage IQC and final product verification for devices and sterile kits.
• Oversee production/storage monitoring and equipment calibration.
• Identify NCRs and deviations; assist in CAPA and root cause analysis.
• Develop hardware/system testing protocols to verify performance.
• Document technical reports and maintain the DHF per ISO 13485 and FDA.
• Participate in ISO 14971 risk management activities.

Skills

IQC

CAPA

Risk management

Documentation

Cross-functional collaboration

Education

Bachelor's or Diploma in Biomedical, Mechanical, or Mechatronics Engineering

Job description

UroMedTech is seeking a detail-oriented Quality Engineer to drive excellence in Operational QC and Design Verification for medical devices and sterile kits. You will safeguard product safety and ensure compliance with international standards and our QMS.

You will manage IQC, final verification, calibration, and non-conformances, while contributing to risk management activities and maintaining the DHF as required by ISO 13485 and FDA guidelines.