SR. QA ENGINEER

SENIOR SOFTWARE QA ENGINEER


TYPICAL RESPONSIBILITIES/DUTIES


Lead Software Quality Assurance activities for projects in the area of real time embedded systems and test tools software. Provide training to project teams on all facets of Software Development Life Cycle to include writing testable requirements, requirements management and tracing, product risk analysis techniques, defect tracking, configuration management, design documentation and verification and validation plans and procedures. Ensure that project activities support business objectives while producing quality software and associated documentation to satisfy customers and regulatory authorities (FDA/ISO). Understand current SQA industry standards and practices and FDA regulations and their impact on internal procedures, software quality, safety and efficacy of products.

?Promote a structured software development process; assure that a state of control is maintained
?Conduct critical analysis, design, and change review meetings for product and non-product software.
?Plan, design and execute software validation test procedures
?Implement automated test methods and tools
?Generate metrics for assessing software quality and evaluate results
?Contribute to process improvements by developing or updating written company or departmental procedures
?Maintain source code configuration control
?Maintain problem-tracking database
?Familiarity with ISO standards


Requirements:

QUALIFICATIONS

?BS or MS in Electrical Engineering, Computer Engineering, or Computer Science
?8+ years of hands-on Software Quality Engineering and V&V experience, preferably with development of medical products
?Medical Device industry or quality assurance experience in developing, recommending, implementing and administering quality policy per corporate
policy and local procedures.
?Knowledge of FDA Quality System Regulation and ISO Quality System Standard
?Ability to develop test applications for small and large scale software products
?Experience programming in C, Visual C++,
?National Instruments LabVIEW a plus
?Strong verbal and written communication skills





To apply online, please use the following link: