What are the responsibilities and job description for the Engineer, Software Quality - Principle position at Experis?
Job Details
Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Lake Forest, IL 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: $30-35/hr on W2
Location: Lake Forest, IL (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.
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.)
Prior validation experience in regulated industries, specifically with GxP applications.
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
Industry: Medical device
Title: Software Quality Engineer
Pay Rate: $30-35/hr on W2
Location: Lake Forest, IL (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.
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.)
Prior validation experience in regulated industries, specifically with GxP applications.
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
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Salary : $30 - $35
