Fred Schofield Email & Phone Number

Rockford, Il, Us

Illinois

Teacher and Coach (Soccer, Cross Country and Basketball at Middle School; JR HS and HS Level) State of NJ, Wisconsin & Illinois for Phys Ed & Health, Biology, Math and Physics (K-12). Certified Teacher PEL in State of Illinois and New Jersey.

Nationally

PROFESSIONAL SUMMARY:• 25+ years of experience in the field of Medical Device Validation/Verification, Instrumentation Data Validation, CSV, DFMEA, Risk Analysis, QA/V&V/IV&V for Embedded RTOS Systems, in the Pharmaceuticals, Healthcare, Medical Device, DOD, and Financials industries• 25+ year’s experience Quality Engineering, CSV validating applications in an FDA regulated environment• 25+ years’ experience working CSV with ISO13485, IEC62304, ISO 9000 series, 820.30 & 21 CFR Part 11 regulations• Includes full Software/System Development Life Cycle (Agile-RUP, iterative, spiral, waterfall and incremental), Software Engineering, CSV, SOA, RUP, UML, OOD/OOA, Enterprise/Web/Distributed Systems, Systems Engineering, Work Flow Validation, Requirements Gathering/Analysis/Design, Unit Level Testing, IQ, OQ, PQ, Software Integration, 510K Submissions, Pre-clinical software, Independent Verification and Validation, Quality Assurance and experience with component-based service oriented architectures.

Abbott Labs, Lake County Illinois

• Review and approved Functional Requirement documents (FRS) in HP Quality Center (QC)-ALM 11 as per Validation Policy and SOP's • Review and approve Validation Test plans (VTP) in HP Quality Center (QC) ALM 11 within following Quality Assurance Library guidelines• Review and approve Process description document (PDD) in Solution manager (SAP) system. As Validation Leader: Instrumentation Data Validation Wrote and executed QRA, 21 CFR Part 11 Assessment, Supplier Quality Audit, Risk Management Plan, Change Control Plan, URS, FRS, DS’s, RTMs, Design Validation Protocols, Issue Tracking, Training Material, Updated SOPs, Updated Work Instructions, Anomaly & Deviation Summary Reports, IQs, OQs, PQs & Validation Reports for packaging lines, which included validation of PLC’s, Vision Systems, Operating Systems/Networks, COTS software packages, Micro Controllers, Configurable software packages (SCADA, LAS and MRP), as well as Custom Built Systems. Authored Test Requirements Analysis scenarios, in order to, to understand user & define the needs for the Guarbo Production Line concerning the Sporanox, Propulsid and Risperdal product line. • Review and approve Functional design document (FDS) in Solution manager (SAP) system • Work with Release management team for authoring Incident reports, review and approve on timely basis • Author System certification and present it to review board.• Peer review and approve Validation Change request documents (VCR’s) in GIS Packet Tracker Application (PTA)• Write Traceability matrix report, Test Summary reports and present it to review board..• Conduct test review meetings with testers and provide review comments.• Proactively work with application leads/analysts to identify changes coming in for the forthcoming releases • Work closely with development team, business analysts to perform testing activities as per schedules• Perform Test case coverage metrics and reporting to the QA Management

Waukesha, Wisconsin

Software Validation & Risk Consultant: Instrumentation Data Validation & CT Scan Recon Image Generation Validation and Software DFMEA Lead for Revolution Project for CT SCAN (Next Generation) and Instrumentation Data Validation.Authored Validation Requirements, Validation Strategy, Validation Plan, Test Cases, Test Procedures, Unit Level Test Strategy & reports for 510K Submission for Revolution RECON Team CT SCAN. Provided regulatory compliance guidance for software applications.Lead, performed, consulted & provided leadership for the QSR System/Record implementation.Wrote and executed Validation Plan, URS, FRS, RTMs (Requirements Trace Matrix), IQs, OQs and PQs and implemented them into HP Quality Center for Manual, as well as, Automated Testing. Performed Requirements & Design Analysis, Feasibility Study, in order to, understand the user needs for RevolutionAuthored Software DFMEA for all software levels (code level up to Services Oriented Architecture Level) for all services, as well as, interfaces.Performed informal and formal Risk Assessment from DFMEA for Obelus and RECON and placed in Reliasoft's xFMEA Toolset for conversion into different reports and reuse.Facilitated Test Readiness discussion sessions with users, analyzed information from users, survey FDA/customer responses, and user behavior on internal and FDA web sitesDeveValidated and verified the satisfaction of requirements for Software Design & Unit Level Testing. As Validation Leader: Wrote and executed QRA, 21 CFR Part 11 Assessment, Supplier Quality Audit, Risk Management Plan, Change Control Plan, URS, FRS, DS's, RTMs, Design Validation Protocols, Issue Tracking, Training Material, Updated SOPs, Updated Work Instructions, Anomaly & Deviation Summary Reports, IQs, OQs, PQs & Validation Reports for packaging lines. All documentation, testing and evaluation pursuant to IEEE & ISO Standards, IEC13485, IEC62304

Sr Principal Validation Consultant for Instrumentation Data Validation, as well as, Oxygen Level Sensor Pacemakers, Salesforce.com & System Software Analyst. Also Alternate Project Lead for JD Edwards to SAP/ERP/MRP implementation & Validation.• Was also the QSR/Validation Lead for Project Bluebird, JD Edwards to SAP/ERP implementation with full signature authority as QSR. Also responsible for Reviewing, verifying & assisting with the 28 Development Specification for Six (7) of the Eight (8) Work-streams for BI/Reporting, Finance, Supply Chain, Technical Services, CAPA, Complaint Handling, Planning & SOX Compliance for Finance.

U.S. Marine Corps (1973 – 1981)Captain - Comm-Elec Officer & Test Ops for Government Contracts.TopGun Graduate, Marine Corps Association Award for Honor Graduate in C&E Schools. Responsible for 15 to 97 technical & non technical personnel.

Certificates, Proramming Languages

Activities and Societies: Illinois & NJ PEL Teaching License National University: Studies toward MS, Software Engineering, BA.

Ba, Biology, Math & Education

Activities and Societies: 4 Years Varsity Soccer, Intramural Director, NJ State Scholarship Recipient all 4 years

Fighter Weapons School Graduate

Activities and Societies: Topgun Graduate: Naval Air Station Miramar, CA 1982

Captain, Electronics