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Computer System Validation Engineer
Ref No.: 18-19946
Location: Northridge, California
POSITION 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 Clients 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.

POSITION RESPONSIBILITIES:
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
BASIC QUALIFICATIONS:
In Order to be considered for this position, the following basic qualification must be evident on your resume.
REQUIRED EDUCATION: 
  • BS in Systems Engineering, Computer Engineering, or Computer Science
REQUIRED YEARS OF EXPERIENCE: 
  • 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)
REQUIRED KNOWLEDGE:
  • 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
DESIRED/PREFERRED QUALIFICATIONS (optional)
  • 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
PHYSICAL JOB REQUIREMENTS:
Physical capabilities to perform the job
  • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.
 Regards,
Ankit Narayan Singh
(AnkitN@Lancesoft.com)
703-889-6767