SUMMARY

• Seeking a career opportunity to utilize my skills and experience in teh high tech and biotech, or medical device industry in Project Management, Business Analytics, Software Quality, Software Verification/Validation (V&V), Software/System Test to participate in teh execution of new product development and sustaining products administration of quality assurance programs, policies, processes, procedures and controls in compliance with internal and external requirements.
• Over 15 years’ Experience as Business Analyst, Project Manager, Test Engineer and Quality Engineer in versatile environments with concentration in Computer System Verification, Equipment validation, Software Verification testing and technical writing with strict adherence to FDA 21CFR, ISO, QA standards, methodology, and testing strategies.
• Review all project / program software work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
• Collaborate with project / program teams to ensure work products comply with procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
• Plan, develop and implement validation plans for new product development in conjunction with R&D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
• Generates documentation at teh project level, including software and system risk assessment (risk analysis), and requirements compliance matrix (ERM).
• Assist in teh analysis of field returns and in - process non-conformities.
• Perform CAPA projects and activities.
• Participate in technical design reviews (Software), Project phase reviews; CCB (Change Control Board) reviews, post market trend reviews
• Apply and improve advanced technical principals, theories, and concepts in teh monitoring and coordination of various design, development, testing, and quality activities.
• Utilize knowledge of embedded systems and application software.
• Utilize knowledge of various Software Development Life cycle (SDLC) models (e.g. waterfall, spiral / iterative, scrum)
• Utilize knowledge of risk management (generation of software and system risk analysis), CAPA, and/or Design Controls.
• Working knowledge of IEC 62304, FDA’s General Principals of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDD
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining solutions.
• Ensure dat product development projects and changes to existing products are conducted in compliance with teh FDA Quality System Regulations Design phases.
• Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements dat support teh market needs.
• Lead and/or participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, SWFMEA, FTA, and risk management report).
• Create and/or assist in teh creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
• Provide guidance and direction for sample size and statistical analysis of verification and validation test results.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Assist, when appropriate with internal and supplier audits.
• Provide Quality support to facilitate teh rapid resolution of product complaints and/or safety issues.
• A result oriented IT professional with experience in QA/Testing, Software Quality Assurance with a wide variety of projects and environments on Client-Server and complex embedded systems environments
• Expertise in developing Installation Qualifications, Operational Qualifications and Performance Qualifications for production processes
• High degree of proficiency in developing and reviewing Verification Master Plans, Verification Summary Reports, Standard Operating Procedures and Standard Working Practices.
• Demonstrated strong knowledge and experience with Design Qualifications (DQs), Site acceptance testing (SAT), Factory acceptance Testing (FAT), Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualification (PQs)
• Proficiency in developing GAP Analysis, Redemption Plans & designing RTM's
• Good understanding of QC/R&D Lab Instrumentation/Environment
• Created use case scenarios and documents work flow and business process.
• Documented business workflows textually as well as in UML diagrams (State diagrams) according to RUP, for teh stakeholder review
• Analyzed and documented Business requirements and detail description of teh software for full understanding of teh business.
• Conducted FRS and URS reviews and walkthroughs with teh designers, developers and stakeholders
• prepared teh UML Use Cases using Rational Rose
• Used Requisite Pro to document requirements, associated change requests with requirements and connected requirements with Use cases.
• Supported IT unit creating functional specification documents for teh design, development and implementation of strategic projects.
• Supported teh assigned project manager with creating detailed project plans assisting in developing, scheduling and tracking project timelines.
• Supported project governance and provided regular project communications to teh project manager and business areas.
• Performed feasibility, adaptability study and risk analysis to identify teh business critical areas from USER perspective.

TECHNICAL SKILLS:

Verification: FDA Regulations, GAP Analysis, RTM, Audit Trails

Bug Tracking: StarTeam, JIRA

Operating Systems: Windows 95/98/2000/XP/Vista/7, Mac OS 9, Mac OS X

Other Tools/Software: StarTeam, Agile Advantage, TCSE, Perforce, SharePoint, HPQC, RTC, Rational Requisite Pro, MS Office, MS Visio, MS Project Professional, Rational Rose, ClearQuest

SDLC Methodology: Agile, V model, RUP, Waterfall

PROFESSIONAL EXPERIENCE

Confidential, Carlsbad, CA

Senior Quality Engineer

Responsibilities

• Develop clinical workflows protocols and execute them on mechanical ventilator
• Collaborate with project / program teams to ensure work products comply with Client procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
• Execute and Review verification protocols and procedure.
• Working knowledge of IEC 62304, FDA’s General Principals of Software validation, ISO 13485, ISO 14971, IEC 60601-1.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining solutions.
• Ensure dat product development projects and changes to existing products are conducted in compliance with teh FDA Quality System Regulations Design phases.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Provide Quality support to facilitate teh rapid resolution of product complaints and/or safety issues.

Confidential, San Diego, CA

Systems Test Engineer II

Responsibilities

• Review all project / program software work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
• Opportunity to contribute broadly to many areas of product security, including but not limited to development of security requirements and design validation methodologies.
• Contribute to security evaluation and threat assessments. contribute to teh security analysis, implementation and verification.
• Collaborate with project / program teams to ensure work products comply with procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
• Plan, develop and implement validation plans for new product development in conjunction with R&D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
• Generates documentation at teh project level, including software and system risk assessment (risk analysis), and requirements compliance matrix (ERM).
• Assist in teh analysis of field returns and in-process non-conformities.
• Perform CAPA projects and activities.
• Participate in technical design reviews (Software), Project phase reviews; CCB (Change Control Board) reviews, post market trend reviews
• Apply and improve advanced technical principals, theories, and concepts in teh monitoring and coordination of various design, development, testing, and quality activities.
• Utilize knowledge of embedded systems and application software.
• Utilize knowledge of various Software Development Life cycle (SDLC) models (e.g. waterfall, spiral / iterative, scrum)
• Utilize knowledge of risk management (generation of software and system risk analysis), CAPA, and/or Design Controls.
• Working knowledge of IEC 62304, FDA’s General Principals of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDD
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining solutions.
• Ensure dat product development projects and changes to existing products are conducted in compliance with teh FDA Quality System Regulations Design phases.
• Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements dat support teh market needs.
• Lead and/or participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, SWFMEA, FTA, and risk management report).
• Create and/or assist in teh creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
• Provide guidance and direction for sample size and statistical analysis of verification and validation test results.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Assist, when appropriate with internal and supplier audits.
• Provide Quality support to facilitate teh rapid resolution of product complaints and/or safety issues.
• Work with teh Test Lead to prepare a detailed Master test plan dat provides a complete list of conditions for testing teh system.
• Record Test Specifications for teh test cases on teh plan.
• Understand teh business requirements and develop test cases to test teh complete functionality of teh application.
• Work closely with teh development team to review and modify teh product specifications as per teh fixes identified for teh bugs.
• Perform Smoke Testing, security testing, GUI testing, Load and Stress, Volume testing.
• Conduct Regression & Functional Testing.
• Review teh requirements and teh Use Case Diagrams to write Test Cases
• Report and Tracked defects through Test director.
• Participate in Walkthroughs and Defect report meetings periodically.
• Perform Black Box testing of teh application
• Perform both Positive and Negative testing according to teh Test case specifications.

Confidential, Rancho Cordova, CA

Systems Test Engineer II

Responsibilities

• Participated in teh writing, update, and execution of Control Pad “Advanced Controller” Procedure, and track most defects on it.
• Test and collect Rotational Pim Pullback Rate data for Validation
• Test and collect Measurements Data for Validation
• Review all project / program software work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
• Collaborate with project / program teams to ensure work products comply with procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
• Plan, develop and implement Verification and Validation plans for new product development in conjunction with R&D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
• Generates documentation at teh project level, including software and system risk assessment (risk analysis), and requirements compliance matrix (ERM).
• Create and/or assist in teh creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Assist, when appropriate with internal and supplier audits.
• Provide Quality support to facilitate teh rapid resolution of product complaints and/or safety issues.
• Provided quality system testing on teh development of medical devices used to facilitate endovascular procedures, enhance diagnosis of vascular and structural heart disease, and guide optimal therapies.
• Participated in teh Design and release of master test plan, system verification plan, test procedures, and test reports.
• Performed quality review and approval on test plans, test procedures, deviations, and test reports.
• Provided feedback during documentation developments (MDI, SDD, SAD, SDP, SRS, Project Plan, and Integration Test Plan) for Advance Controller project before submitting them into agile.

Confidential

Project Manager, Test Analyst & Business Analyst

Responsibilities:

• Supervised teh Design and execution of test cases for verification of software requirements, within an FDA regulated environment.
• Supervised teh design and software development test tools and utilities. Supervised Design and execution of test cases for validation of software tools.
• Prepare Project Plans and review test plans, protocols, and reports.
• Manage traceability between teh software tests and teh requirements/design/risk mitigation.
• Review software requirements, design.
• Participate in failure mode, hazards and risk mitigation analyses.
• Responsible for gathering teh requirements through constant interaction with clients and Business Users.
• Conduct JAD sessions to interact with developer team, operations support team and end customer to understand teh current system and new system functionalities.
• Conducted GAP Analysis between different proposals and projects and suggested efficient methods for TEMPeffective outcomes.
• Developed several Use Cases using teh company templates for better understanding and implementation for developers.
• Assisted teh users during UAT and customer walk through
• Had Hands-on experience with all stages of web and software product management, design and development, from customer research and requirements gathering, interaction design and visual design to prototyping, production and usability testing.
• Updated further review comments and took teh user sign-off on teh documents
• Gave feedback to teh architects and UX team in teh architecture design phase and followed up with them.

  Confidential, West Des Moines, IO

• Project Manager & Business Analyst

  Responsibilities

  • Supervised system testing on credit application, loans, and consumer reporting against SRS and spec.
  • Created test data, maintained regression environment, troubleshoot problems, and resolved defects.
  • Performed functional, integration, regression, and user acceptance tests on e-Commerce projects
  • Performed Initial Analysis of Financial Statements.
  • Acquired teh business needs analytics and teh identification of strategic and financial issues to develop solutions.
  • Created Use Cases, Business Requirements and Functional Requirements.
  • Facilitated Requirement Gathering sessions with various business units.

  Confidential

  Senior Business and Quality Analyst

  Responsibilities:

  • Involved in requirement gathering, which included interviews, brainstorms and meetings with stakeholders.
  • Develop comprehensive test plans
  • Develop software requirement specification document
  • Translate technical requirements into test
  • Used PowerPoint presentations for conducting walkthroughs with teh stakeholders
  • Performed Gap analysis by identifying existing technologies, documenting teh enhancements to meet teh end state requirements.
  • Conducted JAD sessions to allow different stakeholders to communicate their perspectives with each other, resolve any issues and come to an agreement quickly.
  • Identified and created all necessary Use Cases from requirements.
  • Created UML Diagrams including Use Cases Diagrams, Activity Diagrams, Sequence Diagrams, and Class Diagrams using Microsoft Visio.
  • Conducted UAT to make sure dat all teh user requirements were catered to by teh application.
  • Monitored client expectations through client involvement and communication throughout teh lifecycle of teh project; educate clients and stakeholders on teh benefits and risks associated with teh project.
  • Facilitated Requirement Gathering sessions with various business units.
  • Gathered business requirements for multiple simultaneous CORE application management capabilities.
  • Worked with other teams and departments on business requirements and application design.
  • Facilitated meetings with cross functional team members to gather detailed business requirements and teh resolution of design gaps and project issues.

  Confidential

  Quality and Business Analyst

  Responsibilities:

  • Conducted formal and informal interviews withkey businessusers to collect requirements for documenting business and functional requirement
  • Develop comprehensive test plans
  • Develop software requirement specification document
  • Translate technical requirements into test
  • Analyzed teh requirements and identified use case scenarios, created Use Case diagrams, Activity and Workflow diagrams using MS Visio.
  • Documented requirements into Business Requirement Documents (BRD) using MS Excel and MS Word.
  • Followed Waterfall SDLC methodology through teh project.
  • Functioned as teh primary liaison between teh business or user group and teh developer team throughout teh System Development Life Cycle.
  • Involved in creating test plan and test scripts for testing functionality of teh system.
  • Participated in User Acceptance Testing (UAT).

  Confidential

  Quality and Business Analyst

  Responsibilities:

  • Conducted formal and informal interviews withkey businessusers to collect requirements for documenting business and functional requirement
  • Supervises, coordinates and participates in verification and validation testing protocols
  • Negotiate project deliverables and deadlines
  • Analyzed teh requirements and identified use case scenarios, created Use Case diagrams, Activity and Workflow diagrams using MS Visio.
  • Documented requirements into Business Requirement Documents (BRD) using MS Excel and MS Word.
  • Followed Waterfall SDLC methodology through teh project.
  • Functioned as teh primary liaison between teh business or user group and teh developer team throughout teh System Development Life Cycle.
  • Involved in creating test plan and test scripts for testing functionality of teh system.
  • Participated in User Acceptance Testing (UAT).