Role:
Senior Software QA Engineer
Location:
Northridge, CA
Duration: 6 Months +
Description:
"The Senior Software QA Engineer will participate in the execution of new product development and sustaining products and administration of quality assurance programs, policies, processes, procedures and controls in compliance with the evolving and complex US and global requirements of the medical device industry.
The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against client quality system elements including software work products to ensure compliance.
This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic's quality, reliability, and compliance requirements.
This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.
Responsibilities:
Review all project / program software work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
Collaborate with project / program teams to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
Plans, develops and implements validation plans for new product development in conjunction with R& D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
Generates documentation at the project level including software and system risk assessment, analysis, and requirements compliance matrix (ERM).
Chair cross-functional change control boards (known at client as Change Review Group (CRG)).
Assist in the analysis of field returns and in-process non-conformities.
Perform CAPA projects and activities.
Participate in technical design reviews (Software), CCB (Change Control Board) reviews, PQRB (Product Qualification Review Board) reviews, and PAB (Phase Approval Board) reviews.
Support 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 design, development, testing, and quality activities.
Assignments are often self-initiated.
Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
Performs other related duties as assigned.
Basic Qualifications:
Bachelor's Degree in Engineering or Computer Science with 5 years' related experience in engineering and/or quality assurance in a regulated industry (e.g., FDA-regulated, FAA-regulated, DoD, CMMI ML 3+) or Master's Degree in Engineering with 3 years' related experience.
Working knowledge of embedded systems and application software.
Working knowledge of various Software Development Life cycle (SDLC) models (e.g. waterfall, spiral / iterative, scrum)
Working knowledge of risk management (generation of software and system risk analysis), CAPA, and/or Design Controls.
Experience leading a project.
