SDLC QA Engineer

Authors, reviews/audits, and approves project documentation associated with the SDLC to support Corporate, Division, FDA, and other regulatory requirements. Accountable for determining changes or improvements needed to support the QA System and business driven objectives. In addition to these primary areas of focus, will perform project work related to: Infrastructure (Hardware or Layered Software Installations); Application quality; Compliance initiatives; and Validations.

CORE JOB RESPONSIBILITIES

- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Accountable for ensuring that project documentation for the software development life cycle (SDLC) is followed for quality and

non-quality applications.
- Provides project management for validation or SDLC activities including: Client QA time estimates; Provides software validation/QA guidance to clients and QA team; Organizing validation or SDLC material for library or electronic storage; and Coordinate and/or lead validation review board meetings.
- Responsible for assessing risk and applying risk based approach strategies without compromising compliance.
- Recommend system release readiness and generate key project deliverables that are approved by senior managers and reviewed by regulators.
- Responsible for evaluating system (applications, layered software,good communication skills; good organizational skills