Software Quality Engineer - LanceSoft Inc
Irving, TX 75038
About the Job
Title: Software Quality Engineer
Location: Irving, TX 75038
Duration: 12 Months
Brief synopsis
" 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.
Education min. / Experience min.-
- Bachelor s with 8+ years of exp. or Master s with 5+ years of exp.
Top 5 skills/requirements
" 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
Location: Irving, TX 75038
Duration: 12 Months
Brief synopsis
" 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.
Education min. / Experience min.-
- Bachelor s with 8+ years of exp. or Master s with 5+ years of exp.
Top 5 skills/requirements
" 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
Source : LanceSoft Inc
