Senior Quality Engineer

Brisbane, Australia

ResApp Health is developing digital healthcare solutions to assist doctors and empower patients to diagnose and manage respiratory disease. We are a small team combining cutting-edge technology with world-class science to deliver breakthrough mobile health solutions and solve real healthcare problems. We are looking for a Senior Quality Engineer to join our growing team. Working closely with our quality and software development teams, the successful candidate will be responsible for ensuring that our medical device software meets quality and regulatory requirements (e.g. ISO 13485, FDA, MDR) . ResApp is a well-funded startup, listed on the ASX and based in Brisbane, Australia.

Responsibilities

  • 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.

Requirements

  • 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 careers@resapphealth.com.au.

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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.