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Position Details: Software Quality Engineer- Enterprise Platform & Solutions : SA

Location: Milpitas, CA
Openings: 2


Job Title Software Quality Engineer
Relevant Experience 
(in Yrs) 6+ years
Technical/Functional Skills  Deep understanding of FDA Guidance Document on software validation, IEC 62304 and ISO 13485
Must have a minimum of 3 years of Software Quality Assurance experience in medical device industry  
ASQ Certification as a Quality Engineer is preferred
Experience Required Experience required in software quality assurance in medical device industry

Roles & Responsibilities Responsible to develop Software Quality Plan. This includes standards to be used (coding and documentation standards), review and audit plan, configuration management plan, etc.
Must develop Software Requirements Specification (e.g. functional requirements, performance requirements, safety requirements, design constraints, etc.)
Must perform Risk Analysis (FMEA, FMECA, FTA)
Must be able to develop Software Validation Plan (SVP)
Must be able to develop develop Software Architectural Design (architecture diagrams, data flow diagrams, etc.)
Responsible for developing Software Design Specification (SDS), traceability analysis from SDS to SRS and SVP to SDS/SRS
Able to run Unit/Module Test and Write Test Report, Run Integration Tests and write Test Reports, Run System Tests and write Test Reports
Writing relevant procedures such as Software installation procedure
Review and update any necessary documents (e.g., SRS, Risk Analysis, SDS, SVP, Test Protocol and Report, etc.)
Provide overall guidance to the project team on software development planning, Verification & Validation (V&V) including black box testing, software lifecycle processes and methodologies, configuration management, with emphasis on quality assurance and testing best practices in accordance to FDA Guidance and ISO Standard 62304 and 13485
Develop quality documentation for software Risk Management, review and approve software requirements, review and approve software V&V test protocol and reports 
Develop software testing methodologies for production and complaints that are software related
Develop test methods for verification and validation of algorithms
Develop and utilize simulations and models
Generic Managerial Skills Must have strong organizational, analytical and problem-solving skills
Ability to produce time management skills during execution
Ability to work in a team proactively, flexibly in an environment
Education Bachelor degree in engineering or relevant field

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