Senior Quality Engineer, MedTech Devices (ISO 13485)

Halcyon Knights Pty Ltd; Western Australia; Sur place; AUD 150 000 - 210 000; Plein temps

Résumé du poste

Halcyon Knights Pty Ltd, an Australian MedTech innovator, is hiring a Senior Quality Engineer in Perth to drive medical device development, validation and manufacturing readiness. You will ensure compliance with ISO 13485 and FDA requirements while supporting regulatory submissions and supplier quality programs.

You’ll collaborate with engineering, manufacturing and regulatory specialists to advance biosensor and monitoring solutions, manage quality systems and lead continuous improvement across

Qualifications

• 5+ years of quality engineering experience in medical devices.
• Solid knowledge of ISO 13485 and FDA quality requirements.
• Hands-on experience with IQ/OQ/PQ, process validation and V&V.

Responsabilités

• Plan, develop and execute IQ/OQ/PQ protocols for manufacturing equipment and processes.
• Support device design controls, verification and validation activities.
• Manage CAPA, nonconformances and root cause investigations.
• Maintain and improve eQMS in line with ISO 13485 and FDA requirements.
• Support DHF, risk management documentation and regulatory traceability.
• Qualify and audit suppliers, including incoming quality inspections.
• Assist FDA 510(k), IDE and other regulatory submissions.
• Collaborate with engineering and manufacturing teams on process validation and design transfer.
• Support internal audits and regulatory inspections.

Connaissances

Quality engineering

ISO 13485

FDA requirements

IQ/OQ/PQ

CAPA

eQMS

DHF & risk management

Supplier quality & audits

Description du poste

Halcyon Knights Pty Ltd, an Australian MedTech innovator, is hiring a Senior Quality Engineer in Perth to drive medical device development, validation and manufacturing readiness. You will ensure compliance with ISO 13485 and FDA requirements while supporting regulatory submissions and supplier quality programs.

You’ll collaborate with engineering, manufacturing and regulatory specialists to advance biosensor and monitoring solutions, manage quality systems and lead continuous improvement across