Software Quality Engineer

Software Quality Engineer

Relevant Experience(in Yrs) - B.S. in Electrical or Computer Engineering or B.S. in Biological Science or B.A. in Computer or Information Science or equivalent.Ten years or more experience in an embedded environment or ten or more years of experience in a software quality engineering discipline or Software department and management experience in a regulated environment.Strong Software Engineering skills with working knowledge of software lifecycle development process, product and process validation activities.

Technical/Functional Skills - Ability to use Software Quality Engineering techniques and tools to solve product design and process technical challenges.Strong project management skills are preferred.Solid working knowledge of FDA Guidance on the General Principles of Software Validation / IEC 62304 Software Lifecycle Process. Provide an expert knowledge of all regulatory requirements and other compliance areas.Preferred to possess a strong understanding of appropriate Risk Management regulations and guidance standards (such as ISO14971 and FDA Guidance) and thorough understanding in the application of risk management tools (such as Risk Analysis and FMEA and FTA).Strong verbal and written communication skill and must be capable of working independently and in a team setting.A working knowledge of software programming tools (such as C, C++, Java, Assembly, and VBA etc.) is preferred.Operating system: Working knowledge of MS Windows, UNIX, or UNIX-Like RTOS (such as Linux, GNU and QNX etc.) is preferred.Preferred ASQ CSQE or equivalent certified.In-depth Knowledge of writing Validation ProtocolsKnowledge on Audit Process

Experience Required - Experience working in a regulated environment (Medical Device, Aerospace, etc.). This includes knowledge of, and experience with, applicable standards, GxP requirements and applicable regulations.Development experience with any or all: imbedded product software, ATE, customer/product data management, product connectivityStrong knowledge of system development methodologies and software program metricsExperience with system/software Quality Engineering methods, techniques and principles.Thorough understanding of GxP standards and medical device regulatory and compliance environment including: ISO 13485, 21 CFR Part 820 and 21 CFR Part 11.Thorough knowledge of and in-depth experience with system development configuration management and change control processes, testing (V&V), issue tracking and defect management.Experience with cyber security and data integrity requirements, methods and implementation.Experience with a proven track record of implementing appropriate risk mitigation w/in-depth knowledge of ISO 14971 Risk Management and IEC 62366 Software Development Processes.Experience with GxP data collection.Working knowledge of failure investigation processes, computer code static analysis methods and toolsClear and effective communicator (presentation, technical writing, verbal)

Roles & Responsibilities - Provide practical technical challenge to the design and development of a product or process software to drive better product or process software performance and project outcomes.The Product Software Senior Quality Engineer will lead compliance and risk management activities for software projects or software portion of systems projects, and continually improve software quality engineering processes. Improve technical expertise and understanding of regulatory requirements. This individual will assure that robust, reliable and compliant systems are transferred to users, and assure that project software change control is compliant with procedures.Assures that product and quality system software projects are complaint with ASP Computer System Development Process and Verification Validation V&V procedures are followed.Review and approve software project deliverables including specific work products, project plans and configuration management.Assure project team members have appropriate training to perform their respective CSV (Computer System validation) project functions. Support audits; instruct, monitor and work with development partner vendors and suppliers to meet ASP's CSV expectations.Promotes and develops good engineering practices, Guide teams on appropriateness of the software development life cycle activities, assure development and maintenance efforts are effective and compliant.Serve as subject matter expert on software development practices.Support various functional departments project, such as, Operations, Quality, IT and R&D project support. Generate and/or Approve individual V&V deliverables created by the project team including, but not limited to: Project plan, configuration management plan, User Requirements and Risk management documents, trace matrices, Test plan, Test protocols, Code Reviews, Test cases, and V&V summary reportProvide expertise to internal and external auditors on CSV projects and processes. Provide CSV expertise on software development and V&V suppliers conducted by Supplier Quality.Perform computer system validation for the manufacturing, lab machines and equipment's.Responsible for Remediation and perform Audit activities.

Education - Bachelor's degree (or equivalent) in Engineering (software, computer, computer science or electrical) AND 5 or more years of relevant experience