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.
- Work closely with all staff to manage and maintain ResApp’s QMS to an ISO13485:2016 standard and the FDA’s Quality System Regulation (QSR) requirements
- Write and maintain all controlled documents/procedures and ensure the QMS remains compliant
- Managing the training and internal audit program
- 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
- Experience in ISO9001 or ISO13485 or in a regulated environment is highly desirable
- Understanding of Quality Systems
- Attention to detail and strong project management skills
- Excellent written and verbal communication skills with the ability to work collaboratively
- Life Science, Engineering or Law degree or equivalent medical device experience
- Experience with working in the medical device industry, 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 email@example.com.