Engineer, Software Quality

Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Irving, TX for a Software Quality Engineer role to assist their team. This is an on-site role.

Industry: Medical device
Title: Software Quality Engineer
Pay Rate: $36/hr on W2
Location: Irving, TX
Duration: 12 months Contrcat with possible extension or hiring

Job Description:
• 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.