Job Details

  • Title: Software Quality Assurance Engineer
  • Code: RCI-ABT-78169
  • Location: Abbott Park Illinois (IL) 60064
  • Posted Date: 07/09/2019
  • Duration: 11 Months
  • Status: Open
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  Job Description

Primary Job Function:

Responsible for providing consultation and direction to functional areas on IT Compliance.  Reviews and approves IT non-product software compliance system documentation for compliance with Standard operating procedures and applicable regulations.  Conducts quality related actives to deliver consistent; high quality documents and services.

Core Job Responsibilities

  • Responsible for all software quality assurance activities such as evaluation of software lifecycle (SLC) deliverables for compliance with Standard Operating Procedures and applicable regulations.
  • Provides consultation and direction to functional areas on IT Compliance policy, process, and procedures.
  • Lead document reviews, risk analysis and other software quality assurance activities.
  • Performs resource planning and allocation across multiple projects/client areas for  IT Compliance activities.
  • Ensures that documentation is in compliance with policy and procedures 
  • Develops and leads the implementation of testing methodologies and/or IT Compliance practices
  • Provides guidance to staff during review and approval of IT Compliance system documentation.
  • Performs work using standard methodologies, processes and tools to ensure IT Compliance.
  • Develops business relationships and integrates activities with internal and external IT and QA departments to ensure successful implementation and support of project efforts by ensuring consistent IT Compliance practices.  Identifies information required to support the business processes and collaborates in the development of appropriate strategies. 
  • May have indirect functional area supervisory responsibility.
  • Adheres to established policies and procedures.
  • Assists in the establishment of regulated policies and procedures within the organization.
  • Establishes and maintains productive relationships with all levels in the IT organization, division business functions and with external partners.
  • Acts as a liaison and IT Compliance expert to assure successful implementation

Minimum Education

  • Bachelors Degree or equivalent certification or experience

Minimum Experience / Training Required:

  • 3-5+ years’ experience in a quality systems environment, or equivalent combined work experience.
  • Experience with software quality assurance for SAP systems is a MUST
  • Excellent analytical, judgment and consultative capabilities and communication skills and the ability to work with IT management and staff.
  • Knowledge or experience in requirements gathering, analysis technologies, software verification/validation, configuration management techniques or documentation standards.
  • Must be able to manage multiple tasks
  • Sufficiently knowledgeable of regulatory Requirements and industry best practices for computerized system validation to complete tasks review and revision for approval.
  • Understands lifecycle approach as well as risk based approach to quality assurance.
  • Generally familiar with GxP regulations
  • Able to work both independently and as a member of a cross-functional project team
  • Good written and oral communication skills
  • Microsoft products such as; MS Word, MS Excel, MS Project and MS Visio.