Senior Quality Engineer
- Support the quality and software development team in ensuring compliance with quality objectives
- Oversee all technical elements of design history file including product specifications, risk documentation including FMEA based risk assessments, usability assessments and verification and validation applicable to medical device standards.
- Mentor and train the software development team in medical device standards
- Write validation protocols and reports, and perform critical analysis of results
- Develop and support continuous improvement programs and drive a culture to reduce defects, improve overall quality, and achieve operational excellence.
- Bachelor’s degree in Mechanical, Biomedical, Electrical or similar engineering discipline
- 3+ years experience in medical device product development
- Understanding of operating within a quality management system e.g. ISO 9001, ISO 13485.
- Knowledge or direct experience of software development under IEC 62304
- A strong quality-focus with a pragmatic approach to implementation
- Advanced Microsoft Office skills (Word, Excel, Powerpoint)
- Excellent verbal and written communication
- An ability to work autonomously as well as in a team environment
To apply please send a cover email and a copy of your resume to email@example.com.
ResApp Health Limited
ABN 51 094 468 318
Level 12, 100 Creek St, Brisbane, QLD 4000
© 2020 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327, Japanese Patent No. 6,435,257 and Patents Pending. ResApp Health®, the ResApp Health logo and ResAppDx® are registered trademarks of ResApp Health Limited in the United States and other countries. ResAppDx is not available for sale in the United States.