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Regulated Software Development Lead

1 week ago


Lake Forest, Illinois, United States LanceSoft Full time
About the Role

We are looking for a highly skilled Software Quality - Principle Engineer to join our team at LanceSoft. In this role, you will be responsible for reviewing and approving software lifecycle (SLC) deliverables for regulated applications.

Main Responsibilities:
  1. Review and approval of SLC deliverables, including risk classifications, requirements, config/design specs, IQ, OQ, PQ, trace matrix, and summary reports.
  2. Collaboration with cross-functional teams to build compliance capabilities and ensure quality of deliverables meet business needs.
  3. Review of CAPAs, change controls, and defects for GxP applications.
What We're Looking For:
  • Bachelor's degree with 8+ years of experience or Master's degree with 5+ years of experience.
  • Prior experience in regulated industries, including GxP systems.
  • Strong understanding of FDA regulations, including 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485, and ISO 27001.
  • Excellent communication and collaboration skills.
  • Ability to work with various applications/tools, including ALM, TrackWise, JIRA, Confluence, and other integration tools.