Software Quality Assurance Engineer

SCIGON is seeking a Software Quality Assurance Engineer for a contract opportunity in Abbot Park, IL.

Job Description:

  • Be responsible for all software quality assurance activities such as evaluation of software lifecycle (SLC) deliverables for compliance with Standard Operating Procedures, FDA Guidelines include 21 CFR Part 11.

  • Lead or participate in various document reviews, risk analysis, and other software quality assurance activities.

  • Knowledge or experience in requirements gathering, analysis technologies, software verification/validation, configuration management techniques or documentation standards.

  • Must be able to manage multiple tasks and resources.



knowledge and skills (general and technical):

  • Sufficiently knowledgeable of FDA regulatory Requirements and industry best practices for computerized system validation to complete tasks review and revision for approval.

  • understands lifecycle approach as well as risk based approach to quality assurance.

  • generally familiar with GxP regulations

  • Able to work both independently and as a member of a cross-functional project team

  • good written and oral communication skills

  • good problem solving skills

  • Microsoft products such as; MS Word, MS Excel, MS Project and MS Visio.

  • Familiar with information technology principles, functionalities and capabilities of computer systems; and how computer systems relate to and integrate with larger corporate IT infrastructures.



  • Minimum Bachelor’s degree, background in software engineering or software quality assurance. Hands-on professional with experience in the software lifecycle (SLC).

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