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Become part of our multi-disciplinary team working at the intersection of physiology, X-ray physics, fluid mechanics and software engineering. Prospective applicants with natural curiosity and eagerness to continually learn should contact recruitment@4dx.com to learn more.

Current Openings

Posted Sept. 1, 2019

Quality & Compliance Manager

 

4Dx continues to grow!  We are seeking a Quality & Compliance Manager to join our world-class Melbourne team.

4Dx is an expanding med-tech company established to commercialise our novel lung imaging technology. Our image analysis software provides four-dimensional insights into lung function, with lower dose and higher accuracy than traditional medical imaging modalities. As a member of our Quality and Regulatory team you will be pivotal to 4Dx delivering our cutting-edge technology to patients throughout the world.

 

In this job, you will:

  • Develop our Quality Management System
  • Ensure compliance to Software as Medical Device guidance and regulations (for FDA, CFDA, TGA, and other geographies)
  • Ensure patient data privacy compliance for our analysis software and associated systems for the US market
  • Train team members on the function and use of the QMS, quality requirements and regulatory requirements

 

The ideal candidate will possess:

  • Five or more years’ of related quality experience
  • A good working knowledge of standards and regulations, including industry standards FDA 21 CFR Part 820, ISO 13485 and ISO 14971
  • A strong understanding of patient data privacy requirements
  • Experience driving a quality system within an organisation
  • Excellent organisational, communication and collaboration skills

 

Additionally, the following skills and experience would be advantageous, but not essential:

  • Experience working with Software as Medical Device or technology-based product
  • Expertise with IEC 62304 and IEC 62336 and their corresponding documentation
  • Knowledge of the Medical Device Single Audit Program (MDSAP)
  • Knowledge of FDA, CFDA and TGA guidance, regulations and principals

4Dx is an Equal Opportunity employer, and provides a dynamic, supportive work environment. Benefits include flexible working hours and the opportunity to work from home.

For more information: Contact the 4Dx Recruitment Team at recruitment@4dx.com

To Apply: Please click HERE to apply directly on Seek.

Applications close: Friday 27 September 2019