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Reference # : 18-00556 Title : Sofware Quality Validation Engineer (Medical Device)
Location : Northridge, CA
Experience Level : Start Date / End Date : 01/08/2018 / 05/26/2018  
Company: Artech Information Systems
Job Title: Sofware Quality Validation Engineer (Medical Device)
Job ID: 18-00556
Location: Northridge, CA
Duration: 6 months

Job Description:

This person is an important individual contributor in the Quality Assurance function. This person leads Software Quality Assurance activities and projects associated with the development, validation, remediation, maintenance, and retirement of software systems expected to meet regulatory requirements (i.e., 21 CFR 820.70). He/she monitors and enforces the quality of Healthcare Diabetes software systems and their associated processes and procedures. He/she proactively identifies the need to revise existing procedures, assesses the need for improvement and executes on solutions in order to comply with regulations and/or new requirements. He/she serves as an advisor to the organization regarding compliance to non-device-related software regulations, standards, guidance, and procedures.

A successful candidate would work towards supporting and ensuring all Non-product software/tools/spreadsheets are validated prior to formal development and testing:
  • Coordinates appropriate CSV (Computer Software Validation) schedules and activities using robust project management practices
  • Taking a leadership role as a part of the quality team responsible for Computer Systems Validation (CSV) and Remediation and ensure projects are being executed as per Quality System Regulations, and GxPs.
  • Conducting and moderating Planning Meetings, Risk Analysis, and review meetings
  • Provides expert-level coaching and mentoring to the organization regarding CSV standards, regulations, guidance, and best practices
  • Working closely with stakeholders to establish and support development and testing strategies
  • Provide oversight and enhancement of the existing processes as related to CSV
  • Supporting completion of milestones
  • Performs other related duties as assigned

In Order to be considered for this position, the following basic qualification must be evident on your resume.
BS in Systems Engineering, Computer Engineering, or Computer Science

  • Minimum 5 years of experience in CSV regulated industry
  • 3+ years software testing experience
  • 2+ years software quality assurance experience
  • 2+ years in a government-regulated (e.g., FDA)

  • Strong working knowledge of various SDLC models, software testing methods and practices, software quality assurance and development methods
  • Experience with CSV and Software Validation as a part of Part Specific Programs
  • Experience with validation of SOUP and COTS software
  • Experience with risk analysis as associated with Spreadsheet and Application Software Validation
  • Working knowledge of CSV regulations, standards, and guidance (e.g., 21CFR820, FDA's General Principles of Software Validation)
  • Experience with validating across multiple operating systems (Windows, OSX, iOS, Mobile OSs) and cloud based systems

  • MS in Software Engineering, Computer Engineering, or Computer Science
  • Project Management experience and/or certification
  • Experience in Medical Device/FDA Regulated Industry and compliance with IEC-60601, 62304, 14971, 62366
Rajiv Maruthi
Artech Information Systems