Sr Business Systems Analyst
Core
Subject Matter Expert for validation and compliance of Enterprise and Manufacturing Systems (MES, ERP, QMS, SCADA, PLC) in a medical device environment.
Role type
Senior IC Quality/Validation Engineer (GxP)
Builds
Validated IT and OT systems for continuous glucose monitoring devices
Domain
Medical device manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, EU MDR, GxP risk assessments, IQ/OQ/PQ/PPQ, Six Sigma, Total Quality Management (TQM), SDLC validation documentation
Preferred skills
ASQ Software Quality Engineer (SQE) certification, Medical Device industry experience, expertise in 21 CFR Part 11, familiarity with 21 CFR 820
Technologies
Oracle EBS, MES/Camstar, ERP, QMS, SCADA, PLC, Data Historians, EBR, Microsoft Office, Excel, MiniTab
Responsibilities
Lead verification and validation activities including Computer Software Assurance (CSA) and Process Validation; Provide QA/QC requirements and oversight for IT and Operational Technology (OT) systems; Perform GxP risk assessments at system and data-element levels; Design and improve policies, procedures, and quality systems supporting validation and auditing; Apply continuous improvement methodologies to improve product safety and operational efficiency
Seniority
Senior, hands-on IC