Quality Engineer

Job Duties:

-Ensures appropriate review of software products
-Identifies and documents noncompliance
-Monitors quality of software products, processes, and standards
-Education Level: Undergraduate Degree
-Industry Experience: 3 - 5 Years

Request Notes:
*This is not a V&V or Test SW Engineer.
*They need someone that reviews the requirements, ensures all data is accurate, reviews protocols, ensures the right tests were done according to FDA regs and standards.
*Has been on PD teams as the SW QE rep.
*Someone that started in V&V then moved to QE would be good.

POSITION DESCRIPTION
*Works with minimal guidance to support the design, development, test, and market release of software used in both surgical navigation applications and other medical devices.
*Contribute to the processes and tools used to create and test software applications.

POSITION RESPONSIBILITIES
.Actively participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
.Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate software engineering methods and techniques.
*Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release.

EDUCATION REQUIRED
.B.S./B.A. in Engineering or similar related field

YEARS OF EXPERIENCE
.5+ years of previous experience in an engineering position with B.S./B.A.
.3+ years of previous experience in an engineering position with M.S./MA.

DESIRED/PREFERRED QUALIFICATIONS
.Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards.
.Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques