Quality Systems Engineer (Product Quality) in annaliseai Alexandria, New South Wales, Australia
Website annaliseai
This job listing is about annaliseai in Alexandria, New South Wales, Australia 2022 exclusively on jobizille.com
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.
Flexible and remote-friendly working
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 $1000 personal L&D budget, access to LinkedIn Learning, plus opportunities for internal mobility and leadership training to fast-track your career.
Generous parental support including 16 weeks gender-neutral paid parental leave and $10,000 support for egg or sperm freezing.
Do your best work and have fun doing it with unlimited wellbeing leave, monthly meditations, inclusive team events, and lots more!
About Your Role
As the Quality Systems Engineer at Annalise.ai , you will have the unique opportunity to use your knowledge in quality engineering 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 quality engineering throughout the product lifecycle and ensuring the products meet relevant ISO standards and regulatory requirements. You will support the project team as the primary quality representative. You will have the opportunity to learn from a multi-disciplinary team that consists of domain experts in Machine learning/Artificial Intelligence, Clinical Research, Quality Assurance, Software Design & Development and Marketing.
What You’ll Do
- Ensure product design history files meet applicable standards and regulations;
- Manage the NCR and CAPA process;
- Follow up on and drive the closure of investigations in response to non-conforming events and/or deviations; prepare and evaluate internal and external CAPA responses;
- Manage supplier qualification and evaluation including conducting supplier audits. Follow up on and drive the closure of supplier related NCRs and CAPAs;
- Assist in change management and change control process; and
- Support QMS wide system/process validation activities;
Your Skills
- 3+ years’ experience in a similar role
- Knowledge of ISO 13485
- Engineering or Science Degree or equivalent
Nice To Have (but Not Essential)
- Ability to maintain professional internal and external relationships that meet company core values
- Strong understanding of customer and market dynamics and requirements
- Extensive professional written and verbal communication and interpersonal skills.
- Internal Auditor Certified
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 in use by 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: [email protected]. We look forward to hearing from you.
Company: annaliseai
Vacancy Type: Full Time
Job Location: Alexandria, New South Wales, Australia
Application Deadline: N/A
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