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 email@example.com to learn more.
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 firstname.lastname@example.org
To Apply: Please click HERE to apply directly on Seek.
Applications close: Friday 27 September 2019