lorna staedy

software quality engineer ii

About

Detail-oriented Business Analyst with experience in all stages of the software development lifecycle from analysis through implementation. Extensive requirements documentation, testing and validation background. A project manager with strong organizational skills utilized to implement changes to policies, processes, and procedures within the Medical Device industry. A proactive collaborator who is able to build relationships and adapt style to work effectively with individuals at all organizational levels. Specialties: Software Development Lifecycle (SDLC) Project Management Process Improvement Quality Assurance Software Validation and Testing Software Quality Engineering Technical Writing Risk Analysis Lean Principals Training Metrics Management

Country

united states

City

minneapolis

Industry

medical devices

Skill

fda, 21 cfr part 11, validation, quality system, medical devices, software quality assurance, sdlc, project management, testing, design control, capa, v&v, quality assurance, technical writing, lean manufacturing, software documentation, lims, quality control, minitab, analysis, change control

Experience

lab coordinator

boston scientific

2003-1 - 2007-1 · 4 yrs 1 mo

Managed incoming samples for testing and tracked sample testing progress through internal and external labs. Maintained lab metrics and substantially improved the sample flow process using lean principals. Responsible for ensuring Lab Personnel were trained on current SOP’s, Work Instructions, Methods, and Forms pertaining to the Lab. Managed lab supply budget.

executive administrator and project coordinator

boston scientific

1999-1 - 2003-1 · 4 yrs 1 mo

Maintain equipment build project schedule reporting and orders. Prepared labor forecasting models and analyzed new labor forecasting reports. Point of contact for internal customers regarding new and existing equipment needs.

marketing project coordinator

sungard financial systems

1997-1 - 1999-1 · 2 yrs 1 mo

Managed the compilation of project schedules for all products and communicated status to management.

business analyst

boston scientific

2007-1 - 2012-1 · 5 yrs 1 mo

* Managed projects and supported efforts to resolve non-conforming events (NCEs) and Corrective and Preventive Action (CAPA) projects. Member of several corporate teams to improve processes. Provided Quality System and compliance support. * Software system user requirements documentation * Test cases creation * Validated software systems * Streamlined processes using Lean Principals * Software Development Lifecycle expertise * Risk Analysis knowledge * Tech Writing ability

software quality engineer ii

st. jude medical

2013-5 - Present · 13 yrs 5 mos

* Responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the division. * Work with Manufacturing Engineering in the completion of system/software requirements * Create software validation protocols, including tests traceable to system/software requirements * Assist in the completion and maintenance of risk analysis, focused on software related risks * Work with Manufacturing Engineering to execute tests ensuring software/system is validated for use