We are an Australian medical technology company advancing new standards of care for the detection, diagnosis, and treatment of coronary artery disease. We’ve developed the first new approach in 50 years for diagnosing heart disease, the global #1 cause of death.

Artrya’s ground-breaking AI-driven Salix Coronary Anatomy solution helps clinicians diagnose cardiovascular disease within 10 minutes at the point of care, so that they can provide personalised, life-saving treatment plans for all patients, while the patient is still in the waiting room.

The Role

As our Quality Assurance Associate, you will play a pivotal role in executing key quality processes, including CAPA, NCR, complaints handling, feedback analysis, andpost marketsurveillance (PMS). This role requires a hands-on, detail-oriented professional who actively participates in record completion, root cause analysis, and the recommendation and implementation of corrective actions. You will ensure compliance with ISO 13485 and FDA 21 CFR Part 820, while providing data-driven insights and maintaining audit-ready documentation.

You’ll work day-to-day with software engineers, cloud/infrastructure engineers, AI/ML researchers, QA, Regulatory Affairs, and product managers to support the management of quality events across the software development lifecycle. This includes reviewing deviations, nonconformances, complaints, CAPAs, and risk-related issues, ensuring investigations are thorough, traceable, and compliant with applicable regulatory requirements. You don't need to write code,



but you will need to understand software development concepts and how they relate to SaMD products.

Our ideal candidate is a systems or software engineer seeking to transition into Quality. You are interested in applying your understanding of software development to quality event management, investigations, risk assessments, CAPAs, and regulatory compliance activities supporting SaMD products.

At a high level this role will be responsible for:

CAPA, NCR, Complaints and Feedback Management– including executing investigations, root cause analysis and the implementation of corrective actions

Post Market Surveillance– including collaborating with cross functional teams to ensure informed, documented product improvements

Data Analysis & Reporting

Record Completion and Documentation– including completion and maintenance of required documentation (CAPA reports, logs, PMS records and audit trails)

Collaboration and Communication- working closely with Regulatory Affairs, R&D;, Engineering, and Quality teams to ensure alignment onPMS andquality processes.

About you

We want to hear from you if you are ready for the next step in your career where you will be an integral part of the documentation of our products and processes which can help save lives.





To do this you will need a Bachelor's degree in Software Engineering, Computer Science, Systems Engineering, or a related technical discipline and already have some post graduate experience in software development and/or medical device industry.

We are seeking candidates with at least 2 years’ experience in software development, testing, quality engineering, Dev Ops, or a related technical field who are interested in transitioning into Quality and Regulatory Affairs. Experience investigating software defects, production incidents, or customer issues is highly valued, while exposure to medical devices and regulated environments is also beneficial.

Finally, you will have demonstrated exceptional technical writing and editing skills and strong data acquisition, querying, and analysis capabilities, that you are able to apply in identifying trends in complaint data, evaluating CAPA effectiveness, and supporting regulatory reporting.

What we offer

If this sounds like you, be part of Artrya’s journey and be rewarded by knowing you will be instrumental in an organisationthat is 100% aligned to its purpose of saving lives. We offer a competitive salary, a supportive work setting with focus on flexibility and professional growth.

The Executive Team are incredibly passionate and motivated to succeed. You will thrive by adding to our dynamic culturethat will provide considerable opportunity for continued personal and professional growth.

For more information or to see the detailed Job Description, please emailus at ********@artrya.com

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📌 Quality Assurance Associate (Australia)
🏢 Artrya
📍 Australia