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Software Quality Engineer
Ref No.: 18-49857
Location: Milpitas, California
Position Type:Full Time/Contract
Experience Level: 6 Years
Start Date: 07/17/2018
 
Technical/Functional Skills
  • Deep understanding of FDA Guidance Document on software validation, IEC 62304 and basic understanding ISO 13485.
  • Must have a minimum of 5 years of Software Quality Assurance experience in medical device industry
  • ASQ Certification as a Traditional / Software Quality Engineer is preferred
Experience Required
  • Experience in software quality assurance in medical device industry is required.
  • Experience in remediation activities is preferable (in medical device domain).
Roles & Responsibilities
  • Responsible to develop / review Software Quality Plan. This includes standards to be used (coding and documentation standards), review and audit plan, configuration management plan, etc.
  • Must be able to identify and remediate the gaps in Design Input and Design Verification / Validation during SDLC.
  • Must develop / Review Software Requirements Specification as a part of Design Input (e.g. functional requirements, performance requirements, safety requirements, design constraints, etc.) to identify and remediate gaps with respect to Software Design / Verification / Validation
  • Must perform Risk Analysis (FMEA, FMECA, FTA) and identify and remediate Gaps pertinent to Software Risks in SDLC.
  • Must be able to develop Software Validation Plan (SVP)
  • Shall be able to perform / review traceability analysis from SDS to SRS and SVP to SDS/SRS
  • Shall be able to execute / review Design Verification and Validation activities such as running / reviewing Unit/ Module / System Test Protocols and Test Report.
  • Shall be able to perform / review traceability analysis from Product Requirements to System Requirements to SRS to SDD to Software Verification to Software Validation to Design Output.
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