CSV Engineer

Are you a CSV Engineer with 21 CFR Part 11 experience?

SQA is seeking an experienced CSV Engineer to support our Providence-based Medical Device client. The ideal candidate will have a proven track record of delivering quality documentation on time in a fast-paced environment. If you have a high level of attention to detail and flexibility to multi-task, we want to hear from you.

Qualified candidates will create/update validation documentation for off-the-shelf software, custom Access programs, and custom spreadsheets according to established procedures, including:

  • Master Validation Plans
  • Determining requirements acceptance criteria based on risk
  • Test protocols/test cases
  • Test reports and Master Validation reports
  • Traceability between requirements and test steps (Trace Matrix)
  • Executing test plans to exercise the system under test
  • Must have 21 CFR Part 11 experience

Job ID: 1810-5643
SQA is an equal opportunity employer and supports workforce diversity.