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Software Quality Engineer-Medical Device
2 months ago
Job Title: Software Quality Engineer
Location: - Irving, TX 75038
Duration: - 12 Month contract
- 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/Compliance Wire/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
- Interview preferences : • Video
