Manager, Quality

Brisbane, Australia

ResApp Health is developing digital healthcare solutions to assist doctors and empower patients to diagnose and manage respiratory disease. We are building a small team to combine cutting-edge technology with world-class science to deliver breakthrough mobile health solutions and solve real healthcare problems. We are looking for a Quality Manager to join our fast growing team. The successful candidate will be responsible for managing and reporting on all aspects of the quality management system (QMS). ResApp is a well-funded startup, listed on the ASX and we are based in the Brisbane CBD.

Responsibilities

  • Work closely with our QMS consultants to manage ResApp’s QMS per FDA’s Quality System Regulation (QSR) requirements and ISO 13485
  • Write and maintain all controlled documents and ensure the QMS remains compliant
  • Work closely with internal and external regulatory, clinical and software development teams to integrate their design, development and QA documents into the QMS
  • Coordinate management review meetings, including setting times, agendas and review documents

Qualifications

  • Experience in a regulatory environment strongly preferred
  • Understanding of Quality Systems
  • Attention to detail and strong project management skills
  • Excellent written and verbal communication skills with the ability to work collaboratively

Pluses

  • Technical or Life Science degree or equivalent medical device experience
  • Experience with medical devices, including knowledge and experience in interpreting regulatory requirements (TGA, FDA and/or CE)

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.