Job Description Responsibilities: Serve as SQE, working independently on supporting warehouse information. Review test plans and requirement documents. Perform approvals on documents to meet applicable regulations (21 CFR). Support validation on warehouse systems. Support equipment decommissioning. Collaborate on testing plans and approvals. Work with supplier quality and commercial quality teams. Requirements: Engineering/science/technical bachelor's degree. CSV experience in medical devices and 21 CFR (3-5 years, mid-level). GAMP 5 experience. Experience in medical device manufacturing and operations. GAMP 5 certification. Onsite (local resource). CSQE certification. Auditor certification. Team environment, collaboration, independent communication. #J-18808-Ljbffr