Senior Engineer

Halcyon Knights Pty Ltd; Western Australia; On-site; AUD 150,000 - 210,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Quality engineering

ISO 13485

FDA requirements

IQ/OQ/PQ

CAPA

eQMS

DHF & risk management

Supplier quality & audits

Job description

Senior Quality Engineer – Medical Devices | ISO 13485 | Validation

An innovative, venture-backed Australian MedTech company is at the forefront of developing groundbreaking medical technology designed to improve clinical decision-making and patient outcomes during childbirth. With a strong focus on innovation, the business is pioneering next-generation biosensor and monitoring solutions, tackling complex clinical challenges through cutting-edge engineering and technology.

Bringing together specialists across engineering, manufacturing, electronics, clinical research and data science, the business is continuing to develop and advance its innovative medical technology.

They are now looking for a Senior Quality Engineer to join their multidisciplinary team based in Perth.

The Role

This is a hands‑on quality engineering role working across medical device development, manufacturing, process validation and quality management systems.

You will play a key role in ensuring medical devices are designed, developed, validated and manufactured in accordance with ISO 13485 and FDA requirements.

Working closely with engineering, manufacturing and regulatory specialists, you will support product development, manufacturing readiness and regulatory submissions within a growing MedTech environment.

What You'll Be Doing

• Planning, developing and executing IQ/OQ/PQ protocols for manufacturing equipment and processes.
• Supporting medical device design controls, verification and validation (V&V).
• Managing CAPA, nonconformances and root cause investigations.
• Maintaining and improving quality management systems (eQMS) in accordance with ISO 13485 and FDA requirements.
• Supporting design history files (DHF), risk management documentation and regulatory traceability.
• Qualifying and auditing suppliers, including incoming quality inspections.
• Supporting FDA 510(k), IDE and other regulatory submissions.
• Working closely with engineering and manufacturing teams on process validation, design transfer and continuous improvement.
• Supporting internal audits, regulatory inspections and ongoing compliance activities.

We're Looking For A Mix Of The Following:

• 5+ years of quality engineering experience within medical devices.
• Strong working knowledge of ISO 13485 and FDA quality requirements.
• Hands‑on experience with IQ/OQ/PQ, process validation and V&V activities.
• Experience managing CAPA, nonconformances and root cause investigations.
• Experience working with eQMS, document control and quality management processes.
• Understanding of design controls, DHF and risk management under ISO 14971.
• Experience with supplier quality, qualification and auditing.
• Exposure to FDA 510(k), IDE or TGA submissions would be advantageous.
• Experience in electronics or PCBA manufacturing, or knowledge of IEC 60601 and IEC 62304, would be advantageous but is not essential.
• Experience in biosensors, cleanroom manufacturing or a growing MedTech environment would also be highly regarded.