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Senior Software Quality Engineer

Company: Leica Biosystems
Location: Vista
Posted on: May 3, 2021

Job Description:

Nearly every one of us has been impacted by cancer in some way. When you join Leica Biosystems, you're helping make a difference in advancing cancer diagnostics. Join our global Quality Engineering team and help us transform the industry!--The primary role of the--Senior Design Quality Engineer is toprovideQuality Engineeringsupport for software and hardware development projects. This includes providing specific project deliverables, as well as, providing review and guidance forrisk management,verification and validation activities related to the development projects.Highly focused on design and development of software products and quality processes including agile,SaMD, AI/ML, Interoperability.--Responsibilities we will trust you with:Participate in cross-functional teams at variousphasesof the development cycle as the QualityEngineeringrepresentative. Work independently and with project team members to develop design control deliverables including quality plans,design controls deliverables, test methods, and Design History Files.--Supportdevelopment teamsin State of the Art (SOTA) methods and processes for the design, verification and validationofSaMDand AI/ML software products.Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA pre-submissions, 510(k and IVDR CE certifications.Participate in the development and maintenance of product riskmanagement,hazard analysisand FMEAsfor multiple projects in accordance with ISO 14971.Work independently and with project team memberstodevelop and improve product and processes to reduce variability and increase robustness throughout the development cycle for multiple projects.--Prepare regular performance reports for Quality Management Systemsand project development. Maintain associated databases and design reports to reflect management input and changing organizational needs.--Meet company and departmental goals in the continuous improvement of all products, services and processes.-- Your areas of knowledge and expertise that matter most for this role:BS/BA in Engineering/scientific/computer systemsor a technical field8+years experiencein quality field in a medical device, IVDor similarly regulated industryASQ, CSQE or other software quality certifications arebeneficialExperience with software and software/hardware development within a regulated industryincluding strongworkingknowledge of 62304,SaMD,14971Experience with AI/ML, Digital Health, Cybersecurity and InteroperabilityFamiliarity with various software development tools (e.g.configuration management, issue/defect tracking, requirements analysis, etc.).What we have to offer:----Check out our benefits here: employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.Diversity StatementAt 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.

Keywords: Leica Biosystems, Vista , Senior Software Quality Engineer, IT / Software / Systems , Vista, California

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