Quality System Representative

About the role

The Quality System Representative will focus on the continuous improvement of an effective Quality System in accordance with Medical Device Regulation (MDR), Therapeutic Goods Administration (TGA), Food and Drug Administration (FDA), ISO 13485, ISO 27001 and other applicable regulations. You will also be responsible for organising and coordinating office administration and procedures, in order to ensure organisational effectiveness, efficiency, and safety.

Responsibilities

  • Ensure Quality Management System processes are established, implemented, and maintained
  • Report to management on the QMS performance and where improvements are needed
  • Ensure all company policies and procedures are documented in a clear, simple, and concise manner
  • Perform internal audits and represent the company on external audits
  • Ensure that product decisions comply with applicable regulations
  • Ensure bookkeeping. Participating in annual financial audits, making sure that staff get paid correctly and on time, processing invoices, and managing office budget
  • Organise induction programmes for new employees, ensure other staff training
  • Ensure that health and safety policies are up to date
  • Support company employees with day-to-day needs

Qualifications

  • Previous experience working with QMS (preferably ISO 13485), ISMS (preferably ISO 27001), Medical Device Directive (MDD), Medical Device Regulation (MDR), Therapeutic Goods Administration (TGA), Food and Drug Administration (FDA)
  • Willingness to learn about peculiarities of AI in medical imaging
  • Strong knowledge in the interpretation and application of relevant Domestic and International Quality System Regulations and Industry Standards (MDR, FDA, TGA, ISO 13485, ISO 27001, ISO 14971, ISO 62366, ISO 82304
  • Competence in the selection and use of Quality Engineering Tools and Techniques
  • Ability to work independently and in team environment
  • Quick learning and assimilation of new information
  • Excellent verbal and written communication skills in English
  • Microsoft Office experience (Word, Excel, PowerPoint etc.)

We offer

  • 1200 – 1800 EUR Net 
  • Stock option package
  • A chance to work on a product that will impact patient care throughout the world
  • A friendly atmosphere among top experts in Computer Vision and Machine Learning
  • A chance to learn and directly work with the latest technologies in the field of Artificial Intelligence
  • Remote work
  • Flexible hours
  • Professional development opportunities

Our team

You will be joining a closely-knit team of 10 people, consisting of award-winning data scientists and medical specialists. As part of a small team, you will closely work with the COO/CMO and CTO. Working at Oxipit will command a hands-on approach, call for curiosity and a strong sense of ownership. The startup environment will provide you with unique challenges as well as opportunities to make a major impact on the company.

About us

At Oxipit we create AI solutions for global medical imaging.  We aim to bring the latest technology developments to improve patient care. Oxipit story includes many ‘firsts’ – from the first fully autonomous Artificial Intelligence solution for radiological reporting to a completely new method of improving diagnostic quality. From Colombia to Australia we make radiologists both more productive and accurate. We are a research driven organization, celebrating knowledge, yet keeping humble at the same time. We are looking for new team members with a wide range of perspectives and backgrounds to help shape our fast-growing company and make a positive impact in the world.

Apply by sending your CV to careers@oxipit.ai