We are working with an innovative medical technology company on a mission to make heart disease diagnosis and management faster, smarter, and more accessible through innovative digital solutions. About the Role As a Senior Quality Engineer , you'll play a key role in ensuring that our medical devices are developed, manufactured, and maintained in full compliance with international regulatory standards. You will lead product realisation processes, manage design and change controls, oversee risk management, and support continuous improvement of the Quality Management System (QMS). This is a hands-on, collaborative role where you'll work closely with R&D, Regulatory Affairs, and Manufacturing teams to uphold quality excellence across the product lifecycle. Key Responsibilities Develop, maintain, and improve product realisation processes in compliance with ISO 13485 and FDA 21 CFR Part 820. Manage engineering change control systems, including documentation, tracking, and stakeholder coordination. Support risk management and design control activities throughout the product lifecycle. Prepare and maintain Design History Files, Device Master Records, and other regulatory documentation. Participate in internal and external audits as a subject matter expert. Provide quality input for regulatory submissions and technical documentation. Train and mentor team members on quality procedures, compliance, and continuous improvement. About You Bachelor's degree in Biomedical Engineering, Quality Assurance, Regulatory Affairs, or related discipline. A minimum of 4 years of experience in Quality Assurance or Engineering in the medical device industry. Strong understanding of ISO 13485, FDA 21 CFR 820, ISO 14971, and EU MDR (2017/745). Proven experience in product realisation and engineering change control. Excellent documentation, analytical, and problem-solving skills. Strong communication and collaboration skills across technical and non-technical teams. Experience with Software as a Medical Device (SaMD) is highly regarded. How to Apply If you're a detail-oriented QA professional looking to make an impact in the medical device space, we'd love to hear from you. You can send your resume to ljonkman@leadgrp.com.au or jbucalan@leadgrp.com.au .
