Immediate Job Opening - Sr. Quality Engineer - MN Apply
Hi, Please find the below job description and if you are interested, please send me your updated resume to saichandra@intellectt.com. Thank You.
Role: Sr. Quality Engineer
Location: Plymouth, Minnesota
Duration: 24+ Months on W2
Job Description:
Primarily responsible for authoring, reviewing/auditing, and approving project documentation associated with the SDLC to support Corporate, Division, FDA, and other regulatory requirements.
This role is accountable for determining changes or improvements needed to support the QA System and business-driven objectives. In addition to these primary areas of focus, quality assurance will perform project work related to Infrastructure (Hardware or Layered Software Installations), Application quality, Compliance initiatives, Validations, Internal/supplier audits, CAPA system investigation, confirmation, or verification.
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 lifecycle (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 a library or electronic storage, 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, & hardware) implementations or changes for impact on other systems.
Perform inter-and extra- audits divisional audits against Policies, Procedures, Processes, Guidelines, etc. under the guidance of senior QA staff.
Responsible for coordinating, facilitating, and reporting inspections or observations completed for or on CIT.
Recommend modification to CIT quality and non-quality systems and drive changes through the approval process.
Develop and maintain written policies and procedures were related to the SDLC.
Perform Quality Engineering functions related to processing improvements, metrics collection and analysis, and adherence to defined Abbott practices.
Requirements:
Associates Degree or higher and minimum of 5 years, to include experience in one of the following areas
Experience: in a formal software development life cycle (5-9 years).
Experience: in the regulated software environment. (2-3 years)
Project Management in software experience (1-2 years)
