The Senior Software Quality Engineer applies sophisticated techniques to daily tasks and activities. In addition, they apply relevant regulations, standards, GxP requirements, and industry practices to assignments. They will act as a domain guide in routine Quality Engineering and scientific matters and will develop and lead key strategic Quality Engineering/scientific initiatives throughout the organization!
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 aligned with procedures.
“The company in which you have expressed employment interest is a subsidiary or affiliate of Fortive Corporation. The subsidiary or affiliate is referred to as a Fortive Company. Fortive Corporation and all Fortive Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, ancestry, sex (including pregnancy, childbirth and related medical conditions), age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity or expression, and other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1-866-272-5573 or e-mail applyassistance@fortive.com to request accommodation.”
Job Requirements:
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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.
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Assures that product and quality system software projects are aligned with ASP Computer System Development Process and Verification Validation V&V procedures are followed.
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Review and approve software project timelines including specific work products, project plans and configuration management.
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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.
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Promotes and develops good engineering practices. Guide teams on appropriateness of the software development life cycle, assure development and maintenance efforts are effective and compliant.
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Serve as an expert on software development practices.
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Support various functional departments projects, such as, operations, quality, IT, and R&D project support. Generate and/or approve individual V&V deliverables you’re doing built 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 reports
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Provide guidance to internal and external auditors on CSV projects and processes. Provide CSV expertise on software development and V&V suppliers conducted by Supplier Quality.
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B.S. (or equivalent) in Engineering (software, computer, computer science or electrical) AND 5 or more years of relevant experience OR Graduate degree AND 3 or more years of relevant experience
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Experience working in a regulated environment (Medical Device, Aerospace, etc). This includes knowledge of, and experience with, applicable standards, GxP requirements and applicable regulations
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Development experience with any or all: imbedded product software, ATE, customer/product data management, product connectivity
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Solid understanding of system development methodologies and software program metrics
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Experience with system engineering methods, techniques and principles
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Detailed understanding of GxP standards and medical device regulatory and compliance environment including: ISO 13485, 21 CFR Part 820 and 21 CFR Part 11
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Detailed knowledge of and in-depth experience with system development configuration management and change control processes, testing (V&V), issue tracking and defect management
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Experience with cyber security and data integrity requirements, methods and implementation
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Experience with a proven record of implementing appropriate risk mitigation w/in-depth knowledge of ISO 14971 Risk Management and IEC 62366 Software Development Processes
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Experience with GxP data collection
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Solid understanding of failure investigation processes, computer code static analysis methods and tools
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Clear and effective communicator (presentation, technical writing, verbal)