CSV ENGINEER

Overview

On Site
$50+
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

CSV Engineer
Val

Job Details

Hello,
Greetings,
Hope you are safe & healthy.
My name is Kundan Mishra. I am a Technical Recruiter with Altitude Technology Solutions (ATS) INC.
The purpose of this email is to serve as an invitation to discuss the opportunity below with our customer that I think you or your candidate would be a great fit for.
Position: CSV Engineer
Location: Santa Clara, CA
Job Description
  • Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
  • Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
  • Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
  • Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
  • Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional) Plan Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution Traceability Matrix Periodic Reviews System Retirement/Decommissioning
  • Execution of Dry/Test protocol run
  • Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions
  • Perform System Retirement/Decommissioning of systems not in business
  • Work closely with software development and IT teams to establish best practices for quality and compliance.
  • Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
  • Drive continuous improvement initiatives in software development processes, ensuring alignment with the company s quality management system.
  • A Minimum Bachelors Degree in Engineering, Science or related technical field
  • Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
  • Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
  • Experience with non-product software validation, including tools for development, testing, and maintenance.

Thanks & Regards

Kundan Mishra
Sr. Technical Recruiter

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