Job Description:  

The candidate will be responsible for writing and executing software test procedures and test reports for medical devices in compliance with ISO 13485, ISO 14971, IEC 62304, and the QSR.

Responsibilities: 

·      Create test manual procedures based on software requirements.

·         Execute test procedures to verify requirements.

·         Investigate and document software defects.

·         Conduct code reviews (C, C++, Java, C#).

·         Perform regression analysis and prepare regression test plans.

·     Create test reports.

Must have Skills:  

·      5+ years as a Software QA professional in an FDA regulated setting.

·      Experience testing firmware/ software on complex laboratory instruments containing motors, pumps, robotic arms, etc.

·     Ability to work independently and in a team environment.

·      Ability to read and understand code.

·         Ability to work closely with the SW Engineers in developing testing.

·     Thorough knowledge of Software QA process and documentation in a medical device software development environment.

·         Excellent oral and written communication skills.

·         Able to work on multiple projects simultaneously.

·         DOORS experience a plus.