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Software Quality Engineer II : Maple Grove, MN
Location:
Maple Grove, MN
Description:
Additional Location(s): N/A Diversity : Innovation : Caring : Global Collaboration : Winning Spirit: High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high:performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing : whatever your ambitions. Software Quality Engineer IIAbout the Role:At Boston Scientific, the Software Quality Engineer II develops, establishes, and maintains software quality assurance methodologies, systems, and practices that meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals, and priorities. Provides focused software quality assurance support within new product development, operational, or system/services support. Your Responsibilities will Include: : Working within a team of Software Quality Assurance Engineers that support manufacturing, Laboratory, R and D, and IT systems.: Actively contributing to all aspects of Software Quality Assurance activities in an FDA:Regulated Medical Device environment and ensuring that software verification and validation is conducted in compliance with site/corporate policies and procedures.: Perform independent review of design, development, and testing of software/firmware used in Boston Scientific Interventional Cardiology and Peripheral Interventional product lines during their entire System Development Life Cycle, from the Requirements gathering phase to the Retirement phase.: Review and approve documentation associated with qualification planning, intended use, user requirements, hazard analysis, Functional and design specifications, Design reviews, Test Protocols, Requirements trace matrix and Qualification Report along with support documentation for equipment and systems.: Review and approve changes to existing systems from a Software QA perspective making sure changes are implemented in compliance with internal procedures and external standards.: Review test results for GDP compliance and ensure that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed.: Ensures that best software QA practices are employed by all departments so that software/Firmware based systems are developed, qualified, and maintained in a manner that provides assurance that the system conforms to both internal and external requirements.: As required, support site audits, non:Conforming Events and CAPA's.: Establishes and promotes a work environment that supports the Quality Policy and Quality System.: Establish and cultivate internal business relationships to facilitate the completion of tasks. May participate in project teams. What We're Looking For:Required Qualifications: : Bachelor's level degree or higher in Science/Engineering/Software discipline.: 3+ years of related work experience in Software QA and/or computer systems validation.: Experience working in an FDA:regulated industry.: Knowledge of System development life cycle (SDLC) preferably with automated manufacturing and computerized lab systems. Preferred Qualifications: : Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature).: Experience in supporting the manufacturing of medical devices is desired.: Must possess excellent organizational, clear verbal and written communication skills.: High level of attention to detail and compliance and ability to effectively support multiple high priority deliverables at once.: Must be team:oriented with people skills and a posit
Posted:
May 11 on Tip Top Job
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More About this Listing: Software Quality Engineer II : Maple Grove, MN
Software Quality Engineer II : Maple Grove, MN is a Quality Assurance Quality Engineer Job located in Maple Grove MN. Find other listings like Software Quality Engineer II : Maple Grove, MN by searching Oodle for Quality Assurance Quality Engineer Jobs.
Software Quality Engineer II : Maple Grove, MN is a Quality Assurance Quality Engineer Job located in Maple Grove MN. Find other listings like Software Quality Engineer II : Maple Grove, MN by searching Oodle for Quality Assurance Quality Engineer Jobs.