Hybrid QA Engineer – MedTech, Shape SaMD & Design

Lead Group; City of Brisbane; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

Lead Group in Brisbane, Australia, is seeking a Quality Assurance Engineer for Medical Devices to join a hybrid team (2–3 days in the office). You will support product development from design through commercialisation, focusing on design controls, risk management, and compliance with ISO 13485 and FDA requirements.

The role covers V&V activities, CAPA investigations, audits, and maintaining QMS documentation for SaMD projects.

Qualifications

• 2+ years of Quality Assurance/Quality Engineering experience in regulated environments.
• Experience with Medical Devices or SaMD desirable.
• Familiarity with ISO 13485 and design controls.

Responsibilities

• Support design controls throughout product development lifecycle.
• Develop and maintain risk management activities (DFMEA/UFM EA).
• Review V&V records and design documentation.
• Lead CAPA and root cause investigations; drive continuous improvement.
• Support internal and external audits and maintain QMS procedures.

Skills

Quality Assurance

Regulatory knowledge

Documentation

CAPA

V&V

Risk management

SaMD

ISO 13485

Education

Engineering degree

Job description

Lead Group in Brisbane, Australia, is seeking a Quality Assurance Engineer for Medical Devices to join a hybrid team (2–3 days in the office). You will support product development from design through commercialisation, focusing on design controls, risk management, and compliance with ISO 13485 and FDA requirements.

The role covers V&V activities, CAPA investigations, audits, and maintaining QMS documentation for SaMD projects.