As part of our RA / QA team you will have the unique opportunity to use your knowledge in regulatory and quality management systems and your passion for technology to bring to market cutting-edge AI-driven medical devices that positively impact patient lives at scale. Why join us ???? Do work that matters. We're pioneering AI software that will help diagnose medical images and raise the standard of healthcare for millions of people every day. ???? Well-funded and global. annalise.ai has a global presence across APAC, EU and US regions. We're backed by I-MED radiology and harrison.ai (raised Australia's largest Series B of $129m in 2021). ???? Work with a bunch of awesome, genuine people who are passionate about what they do. ???? Make an impact . You won't be another 'cog in the wheel' here. We give full trust and autonomy for you to be heard, to work on the big hairy projects - and to make a real difference. ???? Grow your career with us. We're big believers in lifelong learning. You'll be given a personal L&D budget, access to LinkedIn Learning, plus opportunities for internal mobility and leadership training to fast-track your career. ???? Do your best work and have fun doing it with monthly meditations, inclusive team events, and lots more! Your duties in this position will include, but not be limited to: Responsibilities Maintain and improve the Quality Management System (QMS) and quality-related policies and procedures in accordance with ISO13485, IEC62304, FDA 21CFR Part 820 and other relevant medical device standards and regulations, Champion Annalise-AI's Quality Management System throughout the business to help ensure positive engagement and regulatory compliance, Support the monitoring and improvement of quality objectives and KPIs throughout the business, Support the management of key QMS processes, including but not limited to: NCR/CAPA Document Control Change Control Supplier Management Post-Market Surveillance and Complaint Handling Assist with internal / external audits and management reviews, where required, Manage and support change orders, quality plans and quality improvement projects, Train internal stakeholders on quality principles and processes Must Devote all of your time, attention and skill to the performance of your duties both during normal business hours and at other times as reasonably necessary; Perform your duties faithfully and diligently; Follow lawful and reasonable directions given to you by the Company; and Promote the interests of the Company. You warrant that you are not under any obligation or restriction that would interfere or conflict with your employment in this role or your obligations and duties under this agreement. Experience Minimum - 3 years, work with Quality System in development/manufacturing industry Experience Ideal - 5 years+, work with Quality System in MDs or Pharmaceuticals What We're About We're problem solvers, redefining what's possible in medical imaging through AI Technology. Our mission is to raise the standard of healthcare for millions of patients every day. Yes, we're a technology company and yes, we're leveraging the latest AI technologies, but people are at the heart of everything we do. annalise.ai was formed in early 2020 through a unique partnership between harrison.ai and Australia's largest medical imaging service provider, I-MED Radiology Network. Since then, we've scaled rapidly to over 200 employees worldwide and we're focused on creating AI solutions that help radiologists diagnose medical images. Our first product, the world's most comprehensive AI clinical decision-support solution for chest x-rays, is already available to 1 in 4 radiologists in Australia and rolling out to hundreds more. This solution is capable of detecting 124 findings and was recently featured in peer-reviewed publication, Lancet Digital Health journal. And we're just getting started. Help us shape the future of AI in medical imaging. And most importantly, help us make a real difference in people's lives. What's next If you're inspired by what we're up to, please apply now and we'll be in touch soon. We are proud to be an Equal Opportunity Employer. Diversity's not a buzzword here, it's in our DNA. Diverse perspectives shape our culture and make our work better. That's why we're committed to building inclusive teams that represent a variety of backgrounds and skills. If you need any reasonable adjustments, accessibility assistance or would like to note which pronouns you use at any stage of our hiring process, just contact us at accommodations: [HIDDEN TEXT]. We look forward to hearing from you.