Opportunity to join a Digital Health organization as they ramp up their clinical & quality operations to bring to market their software medical device that is used in treating a disease that could eventually affect almost everybody in their lifetime.
- Design and implement documentation and methods for quality management system according to FDA and ISO:13485 requirements
- Write and update quality documentation in collaboration with stakeholders in company
- Design, implement and maintain electronical archival and document control for the company, with the help of subcontractor.
- Bachelor's degree in Engineering or equivalent.
- 3 years’ experience in Quality within the Medical Device industry, preferable with Software in a Medical Device.
- Ability and willingness to go onsite in Austin 3 times a week.