Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Irving, TX for a Software QualityEngineer role to assist their team. This is an on-site role.
Industry: Medical device
Title: Software QualityEngineer
Pay Rate: $30-35/hr on W2
Location: Irving, TX (100%onsite)
Duration: 12months 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. (Required: Resumes must include the candidate’s Bachelor’s or Master’s graduation year.)
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