Software Quality Engineer

Description

Senior Software Quality Engineer

Location: Greater Los Angeles Area

Duration: 6 months contract to hire

Rate: DOE

POSITION RESPONSIBILITIES

• Review all project / program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
• Coordinate software risk management by utilizing techniques such as Software Fault Tree Analysis and Software FMEAs
• Chair cross-functional software change control boards
• Assist in the analysis of field returns and in-process non-conformities.
• Perform and lead CAPA projects and activities.
• Assist in performing vendor audits and in providing input to the process of qualifying potential software subcontractors.
• Provide training, when required, to personnel engaging in software design and development, software verification and validation, software inspection, software documentation, and software release.
• Participate in technical design reviews, CCB (Change Control Board) reviews, PQRB (Product Qualification Review Board) reviews, and PAB (Phase Approval Board) reviews.
• Provide guidance and direction to other engineers and technical support staff.
• Identify and support cost-saving programs and process improvements.
• Drive SOP/DOP updates or creation of new processes based upon upcoming standards or process improvements.
• Apply and improve advanced technical principles, theories, and concepts in the monitoring and coordination of various software design, development, testing, and quality activities.

BASIC REQUIREMENTS

• Bachelor's Degree in Engineering, Biomedical Engineering, Computer Science, or equivalent.
• Minimum of 5+ years related experience in systems engineering and quality assurance in some combination in a process-advanced environment (e.g. FDA-regulated, FAA-regulated, DoD, CMMI ML 3+)
• Working knowledge of embedded systems and application software.
• Working knowledge of software development tools such as emulators, automated test tools, configuration management tools, defect management tools, and compilers.
• Working knowledge of various product-lifecycle methods (e.g. waterfall, spiral / iterative, scrum)
• Working knowledge of ISO 13485, ISO 14971, MDD, 21 CFR 820, IEC 62304, IEC
• Working knowledge of risk management, CAPA, and design controls.
• Strong working knowledge of various Software Development Life cycle (SDLC) models.
• Working experience with internationally certified quality systems, USFDA Quality System Regulation, and / or other advanced regulatory or process models.
• Working knowledge of project management.
• Ability to effectively manage multiple system level projects / programs.

To find out more about Real please visit www.realstaffing.com