Devin I. McElroy · www.dmcelroy.info ·
Devin I. McElroy, M.B.A.
Six Sigma Green Belt
http://www.dmcelroy.info
Summary of Qualifications
Business Qualifications
n Quality/Regulatory Engineer with almost 15 years experience in Quality Assurance, Quality Control, Regulatory Affairs, and Regulatory Compliance including Field Failure Analysis and Software Quality Assurance
n Conducted internal audits and mock Quality System audits in compliance with cGMPs, QSRs (QSIT), ISO (CE-mark with Notified Body), and CMDR regulations
n Analyzed medical device field failures and manufacturing processes and led multiple process improvement projects using standardized methodologies and industry best practices which included PMBOK, SPC, Six Sigma, FMEA, FMECA, and Design For Six Sigma (DFSS) including DOE and pilot programs
n Prepared numerous regulatory submissions for Class I, II, and III medical devices for national and international distribution in accordance with FDA (CFR), ISO, IEC, MDD, QSR, MEDDEV, JPAL, and TGA requirements
n Managed multiple Quality System processes including Change Control (ECOs, EWOs, MCOs), Document Control, Supplier/Vendor Qualification program, Regulatory Affairs/Compliance, Inspection Readiness, Quality Auditing Program, Nonconformances (CAPAs, NCMRs), and Quality System standardization across multiple sites
n Wrote all level of quality and regulatory documentation, including: pharmaceutical recipes following standardized change/document control processes and GLPs; Quality System documentation, Technical/Design Dossiers, and Essential Requirements Checklists
n Managed department and project personnel within Technical Publications, Quality Assurance, Quality Control, Operational Excellence, Packaging, Labeling, and Distribution (Supply Chain) operations
Technical Qualifications
n Platforms: Windows, UNIX, Linux, and Mac OS
n Applications:
¨ Business: MS Office Pro, Adobe Acrobat Pro, Adobe Technical Communication Suite, FileMaker Pro, FrameMaker, Photoshop, WordPerfect
¨ Process/Analytics: Business Objects, Crystal Reports, BrioQuery, Minitab
¨ Project/Change Control: MS Project, NovaManage, LiveLink, TrackWise, SiteScape, Agile, WindChill
¨ Web/CBT: Adobe Creative Suite – Design Premium, Flash, JavaHelp, RoboHelp, HomeSite, CSS, multiple ftp apps
¨ Architecture/Modeling: MS Visio, System Architect, UML, S88/S95
n Some experience with:
¨ Supply Chain: SAP (ERP system), MES
¨ Project/Change Control: Remedy
¨ CAD: SolidWorks, MathCAD
Education & Certifications
n Six Sigma Green Belt Certification, The Juran Institute
n M.B.A., Technology Management, University of Phoenix
n Bachelor of Science, Business/Information Systems, University of Phoenix
n Vocational Degree, Nursing, Lassen Community College
Work Experience
St. Jude Medical, Inc. California
Sr. Quality Engineer Mar 2008 – Mar 2009
n Managed all Change Control and nonconformance monitoring programs including Corrective and Preventive Actions (CAPAs), Nonconforming Material Requests (NCMRs), Manufacturing Change Orders (MCOs), Engineering Change Orders (ECOs), Engineering Work Orders (EWOs), and document controls using Agile, WindChill, MS Word, MS Visio, SolidWorks, and Adobe Acrobat Pro
n Established and maintained Quality System Management (QSM) processes including: Regulatory compliance, internal auditing program, regulatory inspections (FDA) and external (Notified Body -- KEMA) audits, and brought all Quality System documentation into regulatory compliance (CE, ISO, QSIT, CMDR, MDD, MEDDEV, and JPAL)
n Established and maintained Supplier Qualification/Management program in cooperation with Materials, Purchasing, Incoming Quality Assurance (IQC), and Shipping departments. Responsible for issuing Supplier Corrective Action Requests (sCARs) and following corrective actions through to implementation of satisfactory resolutions
n Created and maintained Technical Files and Essential Requirements Checklists for CE-Mark submissions and maintenance including compliance with Notified Body (KEMA and BSI) requirements for European markets
n Compiled monthly quality system data and wrote analysis reports in support of SPC program using MS Excel, MS Access, MS Word, and Minitab
Intel Corporation California
Regulatory Affairs Writer Nov 2007 – Jan 2008
n Prepared 510k submission for new Class II Medical Device using Adobe Acrobat Pro
n Diagrammed business, system, and regulatory processes using MS Visio 2003
n Wrote all 510k summaries, reports, plans, and letters using MS Word 2003
n Adhered to all FDA and IEC/ISO regulatory requirements, guidelines, and standards
n Created Pilot Plan for new medical device
n Performed and documented research projects for substantial equivalence and conformity using MS Excel 2003
Genentech, Inc. South San Francisco, CA
Sr. Quality Engineer / Sys Analyst / Tech Comm Manager Jul 2002 – Sep 2007
n Developed and implemented general operating procedures, standard operating procedures, work instructions, and guidelines for quality system management using industry best practices and regulations
n Investigated Root Causes and wrote proposed remedial actions for nonconformance management (CAPAs, NCMRs) and change management (ECOs, EWOs) using NovaManage and MS Word
n Diagrammed business, system, and application processes using ISO S88/S95 and UML modeling standards and SIPOC diagrams using MS Visio, PowerPoint, Excel, and LiveLink within Technical Publications and Change Control
n Managed business process improvement and application development projects using Six Sigma methodologies, the Project Management Body of Knowledge (PMBOK), SDLC (system development lifecycle), and FMEA using MiniTAB, MS Word, and MS Project while capturing and documenting user requirements, system specifications, and test cases for QA, QC, and Technical Publications
n Developed and implemented general operating procedures, standard operating procedures, work instructions, and guidelines for quality system management using industry best practices and regulations
n Supervised Technical Editing department and Technical Publications contractors. Created “Statement of Work” for contract employees. Created Request for Quotes (RFQs) for contract positions
n Provided expertise on writing standards, industry best practices, quality system standards (cGMP/QSR), and regulations including GMP (most notably – 21 CFR Part 11 for electronic records), the Chicago Manual of Style, the ACS style guide, the Cambridge University scientific style guide, and industry-wide technical writing applications/tools including Good Documentation Practices
n Developed and managed departmental scorecard (using Business Objects XI, Crystal Reports, BrioQuery, Hyperion Explorer, SQL, MS Excel, Access, Visio, FileMaker Pro, and PowerPoint) and cross-site editorial standards using MS Word, LiveLink (document library), and SiteScape
NETMedia WebWorks, Inc. Pleasanton, CA
CIO / Executive VP / BOD Secretary Sep 2005 – Mar 2007
n Developed technology infrastructure and market requirements using Market Target Management methodologies including SIPOC diagramming, cost-benefit analysis, feasibility studies, and risk analysis
n Created and implemented a document library for company Project Proposals using MS Excel, Access, Visual Basic, Macromedia Studio, XHTML, JavaScript, Photoshop, and cascading style sheets (CSS)
n Researched and directed development of technology solutions and systems, concept documents, user requirements, design and system specifications, and test cases using MS Excel, Word, Access, Project, PowerPoint, Visual Basic, the system development lifecycle (SDLC), and the Project Management Body of Knowledge (PMBOK)
n Managed outsourced technology solution developers while facilitating system specification and code review meetings and facilitated requirements gathering meetings while capturing user, system, interface, and design requirements
n Modeled business, process, system, and application flows using MS Visio and System Architect
n Kept Board of Director meeting minutes
n Created Request for Quote (RFQ) and Statement of Work (SOW) for contractors/consultants
Concord EFS, Inc. Pleasanton, CA
Software QA Engineer / Tech Comm Manager Mar 1999 – Jul 2002
n Managed business process improvement and application development projects using the Project Management Body of Knowledge (PMBOK) and the SDLC (software development lifecycle) using MS Word, Project, and Visio, Access, and System Architect while capturing and documenting user requirements and system specifications for the Technical Publications document development process (including standards and infrastructure) and software development
n Established, implemented, and managed document and template libraries while performing document change/version control and change management functions including Engineering Change Orders, Engineering Work Orders, Software Requirements/Specifications, and software testing all in conformance with FCC and IEEE standards
n Managed Technical Publications Department (covering multiple sites) including workflows and writing standards using FrameMaker, MS Word, Access, PowerPoint, and Visio and developed document standards and template libraries
n Designed and developed web-based applications, materials, sites, on-line help systems, and interactive CBT (computer-based training) CD-ROMs simulating proprietary software application use following the software development lifecycle (SDLC) and the Project Management Body of Knowledge (PMBOK) using HomeSite (HTML editor), DemoShield, InstallShield, RoboHelp, RoboHTML, JavaHelp, CorelDraw!, HTML, ASP, JavaScript, VBScript, and CSS
n Conducted group and individual training sessions on FrameMaker and HomeSite using MS Word and PowerPoint
n Configured retail point-of-sale system protocol converters in the UNIX environment using a proprietary software interface
Garrison Creative Dublin, CA
Independent Consultant / Project Consultant Sep 1998 – Jul 2002
n Created Quotes/Proposals in response to RFQs and RFPs
n Kaiser Permanente:
¨ Read C++ code on code data sheets and documented code classes using Borland C++ Builder, MS Word, and Excel
¨ Supported software development projects while providing project management expertise and best practices
¨ Modeled system architecture using System Architect
n Interprise Ventures:
¨ Captured and documented Functional Specifications
¨ Modeled system and application server call flows for telephony architecture using MS Word and Visio
n Resumix, Inc.:
¨ Researched and used proprietary software applications while capturing error information and functions
¨ Wrote Applications Manuals and User Guides using FrameMaker and Photoshop
n Back2Back Chiropractic:
¨ Developed industry-specific forms and company website using MS Word, HomeSite (HTML editor), and HTML
LifeScan, Inc. (a Johnson & Johnson subsidiary) Milpitas, CA
Quality Engineer / Failure Analyst / Tech Comm Mgr Sep 1996 – Sep 1998
n Managed quality system projects following the software development lifecycle (SDLC) that aligned with the system development team in accordance with FDA, ISO, and IEEE regulations
n Captured and documented software concept documents; software, design, interface, and user requirements; software and interface specifications; code review reports, and software risk analysis reports using MS Word, Project, and PowerPoint
n Liaison between Document Services and Regulatory Affairs and was responsible for ensuring that all quality system documentation and template design rules/requirements were properly utilized within QA and RA
n Worked with Mechanical Engineering, Electrical Engineering, and Statistical Analysis departments writing technical reports for field failure analysis and submitting proposed design changes to the Research & Development department
n Developed and implemented general operating procedures, standard operating procedures, work instructions, and guidelines for quality system management using industry best practices and regulations including document and template libraries and document design requirements and processes
n Supervised contract Technical Writers and Systems Analysts while managing workflow and facilitating employee grievance resolution
SSGI, Inc. Chico, CA
Software QA Engineer / Regulatory Manager Nov 1990 – Sep 1996
n Managed application development, documentation, and product development and distribution projects following the software development lifecycle (SDLC) using WordPerfect, MS Project, and PowerPoint for proprietary software development
n Compiled and wrote company's first 510k submission which was accepted on first pass using MS Word
n Managed company compliance with FDA (cGMP) and ISO regulations for non-biologic medical devices (Class II)
n Controlled and managed all Device Master Records and Batch History Records using DMS (a change management and version control system)
n Managed packaging, labeling, and distribution services including contract employees. Created Request for Quote (RFQ) and Statement of Work (SOW) for contractors
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