Quality Engineer in CA Resume Chip Wertenberger by ChipWertenberger

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Sun City, California 92586 (951) 639-7717

Bachelor of Science in Information Technology (BSIT) – University of Phoenix 2007 Currently enrolled in Masters of Business Administration (MBA) program – University of Phoenix estimated graduation August 2010

Abbott Laboratories – Diabetes Care 04/03/09 – 10/23/09 Configuration Project Manager/Validation Analyst (3 month contract, extended 1month)  Employ FDA Quality System Regulations (QSR), 21 CFR 11, and 21 CFR 820 to develop design and validate test protocols while performing configuration management duties.  Delivered Configuration Validation Plan, Software Design Document (SDD) and Software Requirements Specification (SRS) in support of validation and deployment of complaints handing software (MatrixOne/Enovia) .  Developed flowchart and wrote SOP of defect tracking process to support regulatory requirements for SDLC test phase using Bugzilla  Managed 13 people including 2 business analysts, 6 local testers, and 5 remote testers in protocol test efforts, requirements trace matrix management (RTM), and developed new tester training material.  Collaborated with QA, developers, business analysts, and management to deliver system compliant with FDA regulations and internal procedure.  Utilized all aspects of Project Management including: planning, task prioritization, Work Breakdown Schedule (WBS), Gantt chart creation and maintenance (MS Project), liaison, customer facing, proposal, presentation, project scope, issue resolution, setting expectations, risk management, lessons learned, performance metrics, and tasks related to multi-site projects. Edwards Lifesciences – Vascular Intervention 02/03/08 – 01/31/09 Sr. Quality Validation Engineer (6 month contract, extended 6 months)  Performed Hazard/Risk Analysis (HRA) and Failure Mode Effects Analysis (FMEA) for FDA class III (implantable) medical devices  Completed statistical analysis (with Statgraphics) for Gage R&R studies.  Delivered Gage R&R studies, SOP’s on tool use, and Test Method Validations (TMV).for pin gages, hole gages, kink fixtures, pulsitile flow fixture, digital calipers, tensile testing, grain size count, and other measurement equipment and instruments.  Utilized FDA regulations (21 CFR 820, 21 CFR 11, ISO14971) and internal procedure (CAPA, Essential Outputs) to deliver complaint studies and analysis for transapical and transfemoral stent-fixed aortic heart valve replacement delivery systems.  Completed mechanical design review (to GD&T, ANSI Y14.5, and ISO standards) and design controls for aortic heart valve replacement delivery systems.  Conducted regulatory and compliance gap analysis of design requirements to design controls, Essential Outputs (EO), and measurement methods via production travelers, Bill of Materials (BOM), process instructions, and SOP’s.  Developed fishbone diagrams, PRAETO analysis, process flowchart, and procedures (SOP) for requirements and change control management.  Researched and applied compendial methods (ASTM) where appropriate including grain size, sterile packaging seals, and transport Roche Pharmaceuticals 11/01/07 – 01/03/08 Validation Engineer (1 month contract, extended 1month)  Wrote and maintained the following quality system documentation: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation (PV), validation plans, validation reports, and validation summaries.  Performed Hazard/Risk Analysis (HRA) for laboratory instrument per FDA and ISO specifications and regulations.  Computer System Validation (CSV) of chemistry laboratory spectrophotometer plate reader system for protein assay and large molecule use within the drug metabolics and pharmacokinetics department (DMPK).  Ensured Laboratory Information System Interface (LIMS) functionality and wrote SOP’s for study and lab discovery data per 21 CFR 11, 21 CFR 58, and 21 CFR 820. Abbott Laboratories - Vascular Solutions 01/2007– 09/ 2007 Business Analyst/Validation Analyst (1 month contract, extended 1month)  Completed software test from use cases and audited test protocols in FDA regulated environment for internally developed document control system that contained Device History Files (DHF) and Design History Records (DHR) for Class II and Class III medical devices.  Business and gap analysis for existing Systems Life Cycle (SLC) transition to Abbott based SLC policy, procedures, and guidelines.  Delivered high level flowcharting of current and ‘To Be’ SLC. Hospira, Inc. (Abbott Laboratories spin-off of its Hospital Products Division) 1999–2007 Business Analyst/Validation Engineer (full time, direct employee)  Utilized FDA regulations and industry standard methodologies (GxP, SOx, GxP, HIPPA, PCI, PCI, EU, CE, GHTF, CAPA, ISO14971, ISO13485, Intended Use, and ISO9002) for Class II medical instrument manufacturing site in support of Quality Engineering, R&D Engineering, Manufacturing Engineering, Production, Warehouse, and Software Engineering.


Reviewed, wrote, and maintained quality system documentation (DQ, IQ, OQ, PQ, PV, Validation Plans, Validation Reports, and Validation Summaries) while following FDA and regulatory guidelines (21 CFR 11, and 21 CFR 820, CAPA, QSR, DHR, DHF, DMR, ISO). Accomplishments  Developed Hazard/Risk Analysis – Designed and implemented risk-based approach to system implementation and change for the site.  Primary contributor on the Validation Review Board Member – Reviewed and wrote Validation Plans, Validation Reports, Installation/Operational Qualification (IOQ), test protocols/reports, and Design Qualification (DQ) documents for a large variety of projects including Human Machine Interface (HMI) and Programmable Logic Controllers (PLC).  Performed 20 CAPA and Root Cause Analyses – Analysis of production, design, and IT system problems in accordance with FDA regulations and internal procedure utilizing analytical problem solving techniques.  Implemented Software Quality Assurance Plan (SQAP) – Combined SDLC and Validation Charge Request (VCR) processes into one comprehensive set of process instructions and procedures. Project requirements delivered on time were gap analysis, documentation of process (flowchart), procedures (SOP), accompanying templates, training curriculum, and training. All milestones met or exceeded.  MatrixOne Implementation – Implement and provide process re-engineering for R&D to utilize Product Lifecycle Management (PLM) tool for 3D CAD data in support of Design History Files (DHF) and Records (DHR). Deliverables included DQ, IQ, OQ, PQ, Service Level Agreement (SLA), Validation Plans, Validation Reports, and Validation Summaries.  Performed 20 Computer System Validations (CSV) for Configurable-Off-The-Shelf-Software (COTS), customizable, and product software for Class II medical devices. Deliverables included IQ, OQ, Validation Plans, Validation Reports, and Validation Summaries.  Delivered Asset Tracking Project – Requirements management, database field validation, and team facilitation support for cross-site Asset Management project utilizing CA product (Oracle) ARGUS. Deliverables included a mixture of DQ, IQ, OQ, PQ, Validation Plans, Validation Reports, and Validation Summaries.  Calibration System Upgrade – Database and testing support for Calibration System Upgrade. System decommissioning and data migration plans completed ahead of schedule. Deliverables included a mixture of DQ, IQ, OQ, PQ, Decommissioning Plan, Validation Plans, Validation Reports, and Validation Summaries.  SAP Implementation – Process mapping (blueprinting) phase for SAP implementation for finance, manufacturing, and operations departments.  Configuration Management – Managed configuration of product software in UNIX environment using PVCS.  Managed mixed UNIX environment (SUN and HP-UX) – Attained 99.99% uptime for 8 consecutive years.  Media Storage and Data Security Project – Created SOPs, flowcharts, and processes for Quality System Regulations compliance for media storage, HIPPA, and SOX.  SOX Auditor – Audit of financial IT systems for 2 years.  Safety Review Board Member – Participated in safety reviews and provided safety suggestions. Abbott Laboratories 1996–1999 Sr. Mechanical Designer (full time, direct employee)  Provide design engineering and production support employing all standards (GD&T, ANSI, ISO, IEEE, Shake and Bake, Vibration).  Computer Aided Design/Drafting (CADD) and related standards (GD&T, ANSI Y14.5, IEEE).  Developed inspection/ methods utilizing Computer Numeric Controlled (CNC) machine. Wrote process and maintenance instructions.  As R&D representative for the Material Review Board (MRB) performed many evaluations of fitness of use for manufactured mechanical components.  Design engineering for R&D and manufacturing including (but not limited to): plastics, sheet metal, cabling, keypads, tools & fixtures, interfaces, interconnection, peristaltic pumping, electro-magnetic interference (EMI) and coatings.  Configuration of sub-assemblies for ease or manufacture. Consulting Company 1982 - 1996 Mechanical Designer and Printed Circuit Board Designer  Electro-mechanical design, drafting, and engineering for numerous companies utilizing various electrical and mechanical CAD tools while employing the following standards and methodologies: IEEE, GD&T, ANSI Y14.5, ECO, EO, ECN, CN, CR, ECRN, and test.  Printed Circuit Board designer utilizing IEEE standards and methodologies.

         Certification in Windows 2000 administration (Presented by Global Knowledge) Certification in IT Is a Service Organization (Presented by Ouellette and Associates) Certification in Risk-Based Approach to Software Validation (Presented by Lumina Engineering) Certification in Requirements Management Class (Presented by Integrated Learning) Certification from Institute of Validation Technology on Computer Systems Validation Certification in Quality and Validation (Presented by Quality Edge) Certification in Hi-Performance documentation (Presented by Hospira) Certification in Building Self-Directed Work Teams (Presented by Hospira) Certification in Human Factors Engineering Overview (Presented by Abbott Laboratories)

  ASQ Temecula Section 713 Secretary Toastmasters International, Vice President of Education – Speaking from the Heart club based in Temecula, California

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