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 We're seeking a Quality Assurance Associate to join the team. In this role, you will manage and execute key quality processes, including CAPA, NCR, complaint handling, feedback analysis, and post-market surveillance (PMS). You will ensure compliance with ISO 13485 and FDA 21 CFR Part 820, provide data-driven insights, and maintain audit-ready documentation that supports our ongoing compliance and continuous improvement initiatives. Key Responsibilities Manage CAPA, NCR, complaints, and feedback processes — from investigation through to documentation and closure. Conduct post-market surveillance, trend analysis, and prepare regulatory reports to relevant authorities. Generate reports and dashboards to communicate quality metrics and CAPA effectiveness. Support QMS documentation, internal audits, and training activities. Collaborate with cross-functional teams to ensure quality requirements are met and drive continuous improvement. About You Bachelor's degree in Biomedical Engineering, Quality Assurance, Regulatory Affairs, or a related discipline. Minimum 3 years' experience in a Quality Assurance role within the medical device industry. 2 years experience managing post market surveillance activities and complaint handling in compliance with ISO 13485 and FDA 21 CFR Part 820 (≥ 2 years) Current knowledge of global medical device regulations, including EU MDR (2017/745) and FDA MDR Good understanding of quality system regulations (ISO 13485, 21 CFR 820) and risk management standards (ISO 14971). Experience with Software as a Medical Device (SaMD) is highly desired. How to Apply If you're a detail-oriented QA professional looking to make an impact, we'd love to hear from you. You can send your resume to ljonkman@leadgrp.com.au or jbucalan@leadgrp.com.au .
