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

Industry: Medical device

Title: Software Quality Engineer

Pay Rate: $30-35/hr on W2

Location: Irving, TX (100% onsite)

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.

Ed ucation 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

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.