Charles E. Steiniger
Director, Quality
Mr. Steiniger oversees all quality related activities throughout the organization to include Quality Assurance and Quality Control. Mr. Steiniger who joined Sparta Systems in 2004 as Manager, Quality Assurance led Sparta's efforts to develop a Validation Package, a key value-added component of the TrackWise product line.
Mr. Steiniger is the liaison for hosting and responding to all client audit activities, including vendor questionnaires and audit-by-form sent to SSI, as well as handling all audits performed at SSI by customers and third-party organizations to include the Parenteral Drug Association /Audit Resource Center.
Mr. Steiniger has over 25 years experience in system engineering with specialization in quality assurance, project management, software development processes and methodologies, independent verification and validation, configuration management, and system testing in regulated environments to include: Pharmaceutical; Medical Device; Defense (Army, Navy, and Air Force); NASA; Insurance; and Telecommunication.
Mr. Steiniger has conducted training and performed audits for compliance with SDLC, DoD standards, IEEE, CMM, ISO, 21 CFR Part 11, 21 CFR Part 203 (PDMA), HIPAA, and applicable company SOPs.
Mr. Steiniger currently has membership in the Order of the Engineer and the Parenteral Drug Association. As part of his membership in the Parenteral Drug Association, Mr. Steiniger serves on the Audit Guidance Advisory Board.
Mr. Steiniger earned a B.S. degree from the New Jersey Institute of Technology / Newark College of Engineering. Additional training that Mr. Steiniger has completed includes: TrackWise; Capability Maturity Model; ISO 9000-3/9001; Independent Verification and Validation; 21 CFR Part 11; 21 CFR Part 203 (PDMA); Computer System Validation; PVCS Version Manager; PVCS Tracker; Rational TeamTest; Softbridge’s Automated Test Facility; AutoTester; Centerline QC/Replay; MS Project; Primavera TeamPlay; eRoom; Data Warehouse Fundamentals; and Siebel.
