Engineer, Software Quality - Principle

Title: Engineer, Software Quality - Principle

Location: Lake Forest, Illinois

Duration: 11 Months

Top 5 Skills

• Prior experience in regulated industry - GxP systems.
• Good knowledge of FDA regulations; 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485 and ISO 27001.
• Quality Management Tools and Test Management Tools – TrackWise/ComplainceWire/Veeva, ALM, JIRA etc.
• Knowledge about Data Integrity and prior audit support experience (Internal/External).
• Experience working with Software as a Service (SaaS), Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Commercial-off-the-shelf (COTS) and Custom applications
  
  

Job Responsbilities

• Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications – Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc.,
• Collaborate with the cross functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met.
• Review of CAPAs, Change Controls and Defects for GxP applications.
• Working with Global teams and provide audit support
• Working with a range of applications/tools including ALM, TrackWise, JIRA, Confluence, and other integration tools.
  
  

Educations

• Bachelor’s with 8 years of exp. or Master’s with 5 years of exp.
  
  

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.