Bioptigen is seeking a Software Quality Assurance Engineer to support verification testing of software products throughout the product development lifecycle. Primary responsibilities include the following:
Serve as lead SQA engineer for Bioptigen?s Ophthalmic imaging system.
Author test documentation in accordance with the requirements outlined in Bioptigen?s quality system.
Interface with Project Management and software development on all SQA related activities.
Maintain quality system processes associated with software quality assurance.
Writing and executing system level test protocols using good documentation practices. Includes system level testing of both software, hardware, & documentation.
Troubleshooting system issues and entering problem reports in the defect tracking system
Providing testing support throughout the entire software development process
Update SQA specific processes as required to maintain efficiently and regulatory compliance.
Maintaining test plans, test protocols, & test reports to ensure they are accurate and up-to-date
Serve as an active project team member team
Interface directly with Project Management on testing strategy, schedules, and status
Coordinate all testing software QA activities with other SQA resources
BS degree in Engineering or Computer Science and 5 years experience in Software QA
Proficient with Microsoft Office (Word, Excel, Project, etc.)
SQA experience in a Windows environment
Able to work independently; takes ownership of tasks and executes with little supervision
Strong written, oral, & interpersonal skills
Attention to detail and ability to consistently meet high standards of quality
Demonstrated ability to work and contribute in a team environment
General troubleshooting, problem solving and analytical skills
Programming & scripting knowledge a plus
Ability to travel up to 10%
Familiarity with the following is a plus:
Defect tracking systems
Requirements management tools
Automated testing tools (e.g. MS Team Foundation)
Experience working in a Medical device organization
Understanding of FDA and ISO 13485 regulations for medical devices
104 T.W. Alexander Drive
Park Research Center, Building 2
Research Triangle Park, NC 27709