Job Summary
A healthcare company is in need of a Remote Healthcare Quality Systems Analyst.
Core Responsibilities of this position include:
- Enforcing and iterating on our design change processes
- Assisting in the development, application, and maintenance of quality processes for our digital therapeutic products
- Executing software test cases during all phases of development
Applicants must meet the following qualifications:
- 2+ years experience in software testing
- Must be detail-oriented, possess superior organizational skills and have an inherent curiosity for how software components function
- Must have the ability to work independently and in a team environment, with cross-functional groups
- Willing to learn about the Medical Devices Regulation for the US FDA (21 CFR, Part 820), HIPAA, and ISO 13485:2016
- Or experience as related to Design Controls and Document Controls for medical devices
- Willing to learn the EU MDR 2017-745 or experience
