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ROBERT N

Quality Assurance Director

Occupation:

Quality Assurance Director

Location:

Laguna Niguel, CA

Education Level:

Bachelor

Will Relocate:

YES

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SUMMARY: I am a Certified Software QA/Test Engineer with 16+ years of hand-on, battle-tested and real-world experience in Independent Verification and Validation (IV&V). Working experience in automotive, financial and embedded medical devices throughout all stages of the System Development Life Cycle (SDLC) and methodology (Waterfall, Scrum, Agile and RUP) Empower with the Can-Do attitude, I believe in pragmatic, no-nonsense approach to QA/QC discipline. For the last 12 years, I have managed and mentored a team between 3 to 15 direct reports depending on the size, budget and complexity of a project. includes Experienced with 21 CFR Part 11, IQOQPQ Protocols and ISO Standard (ISO 13485:2003) * Executed and modified automated test scripts to address new implemented features or bug fixes. Senior Software V&V Engineer - Abbott Medical Optics, CA - (10/2008 - 12/2010) * Developed test cases and use cases on Software Requirement Specs (SRS) and Product Requirement Document (PRD). * Created testing protocols and performed verification and validation (V&V) on new releases. * Created traceability matrix between requirements, test cases and test results (HP Quality Center 9.2, MKS, Rational DOORS 9.2). * Working experience with 21 CFR Part 11 and other FDA's compliance regulations (ISO 13485:2003) * Interacted dynamically with Marketing, Business and Project Management teams in clarifying and revising system usability and requirements. * Performed firmware and software verification on embedded devices.

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