SaMD Software Quality Lead
for Idea Evolver in Brooklyn, NY USA
Idea Evolver is an independent Health Marketing, Product Development and FDA Compliance company specializing in Audience Market Research, Software as a Medical Device (SaMD) and Digital Strategy. We improve health outcomes through targeted content and application design.
Notable clients include AstraZeneca, Bluebird Bio, United Therapeutics, Novartis and Horizon Pharmaceuticals.
We are seeking a Software Quality Lead to navigate and manage ongoing regulatory and quality processes of medical device software, including implementation of a Software Quality Management System (QMS) in alignment with US FDA Quality System Regulations and Design Controls. Join a talented SaMD + Golang team working to build first-of-its-kind medical software.
Responsibilities and Duties
- Guide Software Quality team on proper design verification approach, including automated and manual testing (unit, functional, regression and integration testing)
- Manage Software Quality team members on a day-to-day basis
- Guide team on testing automation tools for future implementation to gain testing efficiency
- Guide Software Quality Team in design verification approach as well as testing approach during development phase.
- Ensure Software Quality Team complies with internal Idea Evolver QMS in their activities.
- Reporting to senior management on progress of verification, status of defects and general stability of application.
- Consider approach for future translation testing
- Develop deep knowledge of SaMD product as well as FDA and international standards regarding software verification and validation
<!--block-->Benefits and Perks
- <!--block-->Competitive Salary
- <!--block-->Excellent health and dental
- <!--block-->15 paid days off plus holidays
- <!--block-->Flexible work from home schedule
- <!--block-->Working on projects that bring measurable beneficial impacts to patients facing a diverse range of healthcare related needs
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Job Category: Other / Miscellaneous
Location: Brooklyn, NY USA
Zip Code: 11201
Posted on: 12/02/2019
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