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Senior SW Quality Assurance Engineer

Company: Leica Biosystems
Location: Chaska
Posted on: November 15, 2019

Job Description:

Senior SW Quality Assurance Engineer North America-North America-United States-MN-Chaska * Fulfill the Development QA role for Product Software Development Teams as the design progresses through the development process. Understand the product software design/process life cycle and ensure the creation of documented evidence of compliance to Beckman Quality System and applicable regulatory requirements. * Collaborate effectively with other Dev QA, developers and other functional group team members in defining performance requirements, conducting risk analysis, and verification test plan execution. Drive to achieve Design for Reliability results by effective use of applicable Danaher Business System tools. * QA support to Beckman software product development projects in areas of Quality Systems (Design Control) and Quality Assurance (DHF compliance). * Work with other Dev. QA to complete assigned project, procedural, assessments, or data analysis task or as delegated to quality function specialists within the organization. * Contribute to overall success of the project schedule and accomplishment of QA function deliverables to the project. * Ensure that assigned task are compliant to Beckman applicable procedural requirements as well as to FDA QSR, IE 62304:2016; ISO 13485, and other global regulations * Design Control: Complete tasks related to completion of Design Input documents, Verification & Validation data review, Risk Management, Design Transfer, and other associated Dev. QA function deliverables. * Quality Assurance: Effective interaction with members of the Dev. QA function to ensure that product Design History File documentation is organized, complete per applicable procedure, and compliant to the FDA and international regulations. * Process and Procedure Improvement: Complete tasks related to supporting Dev. QA process and procedure improvement initiatives. * Bachelor Degree in Software Engineering, or BS in Engineering or in related technical field with minimum 5+ years of experience or Master s degree in the field with 3+ years of experience or Doctoral degree in the field with 0-2 years. * Demonstrated knowledge of software system risk assessment, modular design concepts, software verification testing, and software requirements development and traceability. * Fluent in English language * Proficient in word processing, electronic documentation systems, spreadsheets, and project management tools * Well-developed skills in writing, review documentation, and oral communication within a technical team. * Ability to influence decisions within Dev QA function and across functions within product line or project. * Experience in a regulated industry specifically knowledge of IVD and Medical Device industry * Ability to support several projects simultaneously while effectively adapting to changing project parameters * Mobility Requirements: Stand/Sit/Walk 8 hrs. /day; ability to travel across campus and between facilities. * Dexterity Requirements: Able to use computer & monitor to develop, review and communicate job-related documentation. * Vision requirements: Correctable to 20/20 in 1 eye and 20/40 in other eye. Able to use computer & monitor to develop, review and communicate job-related documentation. * Hearing requirements: Able to participate in meetings and conference calls and to use a telephone. Diversity & InclusionAt Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Full-time

Keywords: Leica Biosystems, Burnsville , Senior SW Quality Assurance Engineer, Engineering , Chaska, Minnesota

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