We're problem solvers, driven by a simple desire to do work that matters. We're constantly evolving ourselves and leveraging the latest AI technologies to create elegant, innovative solutions across the medical imaging sector.
Annalise.ai was formed through a unique partnership between Harrison.ai and Australia's largest medical imaging service provider, I-MED Radiology Network. Leveraging our diverse and extensive medical imaging dataset, Annalise.ai is developing tools to assist Radiologists by seamlessly integrating into their current workflow to provide diagnostic support. Our suite of comprehensive AI-solutions will support radiologists during their end-to-end process of imaging interpretation.
About your role
Reporting to our Senior QA Manager, as QA Engineer you will be in a unique position to drive the quality culture of Annalise.ai and help make a positive impact on the lives of our patients and their families. The primary purpose of your role is ensure our Quality System is maintained and up to date, supporting compliance with both local and international regulatory requirements.
Our QA Engineers work in a dynamic team of Regulatory Affairs and Quality Assurance specialists, collaborating closely with various departments including Software Development, Software Test, Product and various others. You will therefore be a collaborative team player with a passion for bringing good ideas to life and an enthusiasm to help drive the future direction of our Quality System. Your passion for learning will be demonstrated by your initiative to learn new tools and products as well as identify opportunities to improve our current processes and standards.
What you'll do:
Assist to manage implementation of the company’s quality system and associated records;Assist QA/RA to document and resolve CAPA’s, ensuring timely implementation and closure;Review product documentation for accuracy including documentation intended for customer use;Identify non-conformances and create / maintain records and seek closure; Assist QA to release product and complete records;Perform document control functions for the company; andEnsure records are maintained in traceable and readily accessible formats.
What will help you succeed:
Ability to implement quality and regulatory procedures to meet organisational objectives;Able to communicate effectively to drive execution, foster innovation, focus on the customer, collaborate with others and solve problems creatively;Biomedical Engineering Degree or equivalent;Strong analytical skills; andStrong understanding of customer and market dynamics and requirements.
Nice to have (but not essential):
3 years’ experience in Medical Devices or Pharma industry;Internal Auditor Certificated;Experience in Six Sigma/ Lean Engineering/ Process Improvement Projects; andSome experience in leading or managing direct reports.
Why you'll enjoy working here:
Do work that matters - we are pioneering innovative and cutting edge AI technologies across the medical imaging sector to help make real, positive impact on patient outcomes around the world.Flexible work - we value life at work and life outside of work. Plenty of flexible work options available with us.Grow your career with us – you'll be given a high degree of autonomy to make your mark in this role. In addition, we are big believers in lifelong learning and will support you to cross-skill in whichever direction you may choose to enhance your career.Competitive remuneration – we know this isn't everything, but it's still an important consideration!We're a start-up with a unique culture - with inclusive social activities, wellbeing initiatives and collaborative team events, we celebrate achievements together and take care of our people.Beautiful office space - located in the heart of Sydney's CBD at Wynyard. Note: our office remains open but we are mostly working remotely and support flexible working.
Thank you for considering this opportunity with us! If this role is of interest to you, please apply now and we'll look forward to reviewing your application shortly.