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QA Validation Engineer

Date Posted: 6/5/2017

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Job Description

My Client has an urgent need for a QA Validation Engineer. They are responsible for the test planning, execution, validation and the quality assurance of our enterprise validated laboratory information management systems (LIMS) including other business application systems.

Responsibilities

  • Plan, design, develop and execute test plans and test cases ensuring thorough coverage and traceability to business and functional requirements.
  • Writes and reviews validation documentation including validation plans, risk assessments, test scripts, data migration plans/reports, traceability matrix and summary reports.
  • Review business requirements, functional requirements and technical specifications for software development projects.
  • Convert requirements and specifications into written test plans, test cases and test scripts.
  • Analyze requirements, develop test plans and test cases translating from requirements and preparing test data.
  • Work closely with development and project management teams during application design and development sessions.
  • Focus on quality issues across multiple projects, major changes and releases.
  • Provides guidance with functional/ end user requirements, compliance and system specifications, and ensures that proper documentation is maintained.
  • Identify and analyze software quality assurance risks and any mitigations.
  • Perform periodic reviews and remediation activities on validated systems with Regulatory team.
  • Assist with audits such as CAP, ISO, FDA etc. to provide necessary procedures and documentation.

 
Experience/Education

  • 5 years’ relevant experience as working as a Software QA Validation Engineer in a highly fast-pace, scalable and reliable IT environment.
  • Experience with automated systems for the following activities/functions preferred
    • Laboratory Information Management System/Laboratory System (LIMS/LIS)
    • Quality Management System/Document Management (MasterControl/SharePoint)
    • Requirements and Testing (Microsoft TFS/HP ALM/HPQC/JIRA)
    • Change/Incident Management (Microsoft Service Manager/System Center/TFS)
    • Project/Task/Workspace Management (Microsoft project, Team, Slack, Yammer) 


 
  Knowledge/Skills/Abilities

Familiar with Software Development Lifecycle Management (SDLC) and Change Management methodologies

  • Knowledge of Regulatory Procedures FDA 21 CFR Part 11 and ISO9001 with good understanding of related processes including risk based approach and validation.
  • Ability to engage, interact, and negotiate effectively with IT, QA, validation and business project team members.
  • Knowledge of applicable data privacy practices and laws including HIPPA, PHI and CAP.
  • Good analytical and problem solving skills.




We are an equal opportunity employer.

Job Requirements

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Posted By: arahmatullah@ledgent.com

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Job Snapshot

  • Employee Type:Full-Time
  • Location:Irvine, CA
  • Job Type:Health Care
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:6/5/2017
  • Contact: Ahmed Rahmatullah (714) 940-5420
  • Pay Range: $35.00 - $45.00 Hourly
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Job Reference: 000854