SUMMARY:

• James Runde has over 25 years experience in business analysis, software verification, Quality Assurance and Regulatory Affairs. He has submitted software/regulatory documentation for review and approval to the Food and Drug Administration, Department of Defense, Department of Energy, and the Nuclear Regulatory Commission.
• Business Analysis. Extensive hands-on experience in requirements analysis and writing/reviewing business processes, requirements specifications, use cases, test plans and reports. Creation and review of functional and technical requirements across multiple projects, including gap analysis, documentation of business processes, workflows and requirement traceability matrices.
• Software Verification. Subject matter expert verifying software using CMMI, IEEE, ISO and UL standards. Expert in using Institute of Electrical and Electronics Engineers IEEE documentation standards for systems and software development, testing and IV V. Background includes reviewing requirements, writing test plans test cases, executing tests and writing test reports. Extensive experience establishing QA departments and improving existing QA processes, including mentoring and training. Background includes working in Agile environments.
• Quality Assurance. Developed several QA departments from scratch. Familiar with IEEE QA standards, ISO 13485, 21 CFR Part 820, ISO 14971, 21 CFR Part 11, HIPAA Privacy Security Rules and Texas privacy statues and regulations. Audited and improved Quality Assurance programs by performing gap analysis, improving business processes and rewriting Standard Operating Procedures.
• Risk Management. Subject matter expert in ISO 14971 Risk Management for Medical Devices. Risk management documentation has been approved by ISO/FDA in three countries United States, Canada and Netherlands . Established ISO 14971 programs and conducted complete risk assessments, including FMEA, FTA and PFMEA analysis. Risk management efforts also conformed to IEC 60601-1 3rd Edition.

KEYWORD SKILLS SUMMARY:

• Quality Assurance, IEEE Standards for System and Software Verification and Validation, requirements analysis, system documentation, Independent Verification and Validation IV V , software testing, Agile, 21 CFR Part 820, ISO 13485, Quality System Regulation QSR , 21 CFR Part 11
• MMIS, Medicaid, HIPAA compliance, Section 508 compliance, gap analysis, risk management, Agile methodologies
• Requirements analysis and documentation, technical design review, test plans, use/test cases, test procedures, test reports, requirements traceability matrices, user acceptance test UAT and redesign of operating procedures/business processes

EXPERIENCE:

Confidential

QA / ISO 14971 Consultant

• Provided consulting services to medical device manufacturers. Reviewed business processes and audited Quality Systems for adherence to 21 CFR Part 820 and ISO 13485.
• Performed 21 CFR Part 820, Quality System Regulation QSR and IEC 60601-1 3rd edition gap analysis
• Wrote Standard Operating Procedures improved CAPA processes, complaint handling reporting
• Established ISO 14971 programs and business processes from scratch.
• Conducted over seven complete ISO 14971 risk management projects, two of which incorporated IEC 60601-1 3rd edition. Results were approved by ISO/FDA in three countries: United States, Canada and Netherlands
• Conducted comprehensive risk assessment activities: Hazard Analysis, identifying causes and risk controls. This included Fault Tree Analysis FTA , Failure Mode Effects Analysis FMEA and Process Failure Mode Effects Analysis PFMEA . Investigated complaints, performed root cause analysis, initiated CAPA items as required and monitored closure of items
• Mentored employees on Quality Systems and ISO 14971
• Keywords: 21 CFR Part 820, Quality System Regulation, ISO 14971, IEC 60601-1 3rd edition, SOPs, Risk Assessment, Gap Analysis, CAPA, risk management plans reports, FTA, FMEA/PFMEA

Confidential

Independent Verification Validation Consultant at

• Independent verification and validation IV V support for the Texas health and Human Services commission HHSC Medicaid Eligibility and Health Information Services MEHIS system
• Verified the system complied with IEEE Standard 1012 Standard for System and Software Verification and Validation.
• Verified software system complied with HIPAA Security and Privacy Rules. Identified sensitive data categories. Monitored compliance with Section 508
• Served as a liaison between HHSC, Medicaid stakeholders and software developers
• Interfaced with and used Medicaid processing systems for testing purposes
• Reviewed requirement specifications, technical requirements, use cases and test plans. Wrote User Acceptance Tests
• Monitored and evaluated vendor performance, verified deliverables, performed site reviews and confirmed system readiness
• Mentored state employees on QA best practices. Documented business processes
• Reviewed software and QA requirements for ICD-10 conversion
• Keywords: Medicaid, best practices, IV V, IEEE standards, HIPAA Privacy and Security, HP Quality Center, relational database, client-server, Section 508 compliance, requirements analysis, use and test cases

Confidential

Software Quality Assurance Manager

• SQA manager for a start-up company. The product scanned the internet and organized, filtered and delivered customized business intelligence reports for customers.
• Instituted QA procedures and wrote business processes
• Analyzed and documented business requirements. Wrote software requirements and functional specifications. Documented software testing: Test plans, cases, procedures reports
• Executed tests and reported results. Wrote custom test software using C , Java and php
• Keywords: SQA testing, QA best practices, API testing, user documentation, test documentation, relational database, client-server

Confidential

Quality Assurance Specialist / QA Architect

• Quality Assurance expert for software test automation firm. Advised clients on how to improve their QA processes and implement automated testing.
• Analyzed and documented business requirements. Wrote software requirements and functional specifications. Wrote and documented business processes
• Wrote client test plans/designs test cases and automated test scripts
• Wrote custom test programs in C/C and C
• Wrote business proposals, including a keyword-based testing approach rated by the client as superior to submissions by CSC and EDS
• Reviewed software for Section 508 compliance
• Taught training classes to clients on user documentation and testing tools. Wrote Quick Start Guides, user manuals
• Mentored and trained clients on QA and software testing. Developed business processes and workflow diagrams
• Keywords: SmarteScript automated testing tools, QA best practices, software verification, test plans, QA architect, relational database, client-server, Section 508 compliance

Confidential

Director of Quality Assurance

• Overhauled the QA and software testing processes for a medical device manufacturer. Rewrote software development and verification SOPs and procedures to conform to 21 CFR Part 820 and ISO 13485. Promoted to Director of Quality Assurance.
• Responsible for all quality assurance and quality control activities
• Responsible for all software verification and validation activities, including requirements analysis, design control, testing, configuration management and requirements traceability
• Investigated complaints, performed root cause analysis, initiated CAPA items as required and monitored closure of items
• Mentored and trained employees on QA best practices and Quality System Regulations. Conducted in-house training classes and wrote training guides. Developed business processes and workflow diagrams
• Participated in three ISO and one FDA audits. Responded to audits by outside companies
• Implemented ISO 14971 risk management program
• Conducted CFR Part 11 audits and verified compliance
• Responsible for requirements analysis, use/test cases, software test plans and software test efforts
• Established risk management procedures, QA best practices and software standards. Wrote and edited Standard Operating Procedures SOPs
• Conducted Process Failure Mode Effects Analysis PFMEA of manufacturing processes. Performed Fault Tree Analysis FTA for software products
• Keywords: ISO FDA standards, FTA, FMEA/PFMEA, configuration management, mentoring, user documentation, test planning, relational database, client-server, business requirements analysis management, use/test cases, Section 508

Confidential

Systems Analyst

• Established QA procedures and best practices for the Texas Education Agency TEA .
• Analyzed and documented business requirements. Wrote software requirements and functional specifications. Evaluated automated test tools, wrote test scripts and recommended candidates for purchase
• Mentored employees in white- and black-box testing techniques
• Keywords: C , Java, SQL Server, Robot, Mercury Test Products, test planning and documentation, relational database, client-server

Confidential

QA Consultant

• Verification and testing of network- and web-based software.
• Wrote test plans, test scripts and custom C programs to verify XML-based software in .NET and Java environments. Wrote several white papers on user testing
• Analyzed business requirements. Wrote software requirements and functional specifications.
• Reviewed software for compliance with Section 508
• Wrote automated test scripts in Rational Robot, QuickTest Pro and WinRunner.
• Mentored employees in white- and black-box testing techniques
• Keywords: C , Java, .NET, SQL Server, WinRunner, Robot, RUP, XML, Test Director, XML, UML, white-box, black-box testing, HP Quality Center, relational database, client-server

Confidential

Consultant

• In-house IV V expert. Called continually over a period of nine years to perform independent verification and validation of radiation monitoring software. Documentation was reviewed by the Nuclear Regulatory Commission NRC , Department of Energy and QA departments of several nuclear power plants
• Analyzed requirements, design documentation and source code. Updated software and system requirement specifications
• Created traceability matrices, developed overall test plans and test procedures, performed V V testing and published test reports. Wrote business processes
• All documentation was in compliance with IEEE standards for software design and verification
• Established configuration management baselines and procedures, including software control change procedures. Wrote test programs in C
• Keywords: Nuclear Regulatory Commission, IEEEstandards, C , SQL Server, WinRunner, CMM, test documentation, HP Quality Center, relational database, client-server

Confidential

Consultant

• Performed systems analysis of TRIGA, a research reactor used by universities, labs and medical centers in 24 countries throughout the world
• Established wrote QA practices and policies, project plans, software baselines, and configuration management.
• Recommended algorithm modifications and user interface improvements
• Updated software and system requirement specifications. Documented and improved business processes
• Prepared Capability Maturity Model CMM plans/reports to verify compliance with Levels 2 and 3
• Keywords: real-time, C/C , scripts, GUI design, CMM/CMMI, audits, recommendations to improve capabilities, relational database, client-server