Quality Systems Specialist

Annalise in Chennai, India

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.
đŸŒ± 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!

About Your Role

As the Quality Systems (QS) Specialist at Annalise India Centre (AIC), you will have the unique opportunity to use your knowledge in 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. Your role is to support the maintenance of the Quality Management System and facilitate compliance of AIC to ISO 13485 standards and any other international requirements. You will manage the Document Control process, NCR/CAPA, and Supplier management, and ensure QMS training is up to date. You will have the opportunity to learn from a multi-disciplinary team that consists of domain experts in Machine learning/Artificial Intelligence, Clinical Research, Regulatory Affairs, Software Design & Development and Marketing.
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: people@annalise.ai. We look forward to hearing from you.
    • Manage document control process and assists with daily operational aspects of change management;
    • Perform the function of Document Controller;
    • Manage quality documents / records in compliance with ISO 13485 requirements;
    • Manage the NCR/CAPA system including follow up with owners, support the management of Effectiveness Monitoring tasks and documentation processing;
    • Maintain QMS registers for tracking and trending QMS quality data;
    • Plan, facilitate and minute Quality System Management Review meetings. Follow up on actions arising from the review meetings.
    • Schedule and document outcomes of internal and supplier audits including follow up on any actions resulted from the audits.
    • ·Manage internal training system to ensure that QMS training is implemented and recorded
    • 2 years experience in a similar role
    • Knowledge of ISO 13485 or ISO 9001 Standard or equivalent
    • Engineering or Science Degree or equivalent
    • Experiences in working in or managing databases
    • Strong attention to detail
    • Effective and written skills and ability to engage with all staff
    • Excellent knowledge in MS Word, PowerPoint and advanced MS Excel
    • Strong analytical and problem-solving abilities, including ability to identify issues, communicate and escalate quickly, when required
    • Experience in or knowledge of six sigma/ process improvement Be willing to learn and expand regulatory knowledge in other international jurisdictions
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