What are the responsibilities and job description for the Principle Software Quality Engineer position at Global Technical Talent, an Inc. 5000 Company?
Job Title: Principle Software Quality Engineer
Location: Lake Forest, IL
Duration: 12-month Contract
Work Type: Onsite
Pay Range: $40.29
Brief synopsis:
Global Healthcare Innovator
Location: Lake Forest, IL
Duration: 12-month Contract
Work Type: Onsite
Pay Range: $40.29
Brief synopsis:
- 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 ensure the quality of the deliverables and the business needs are met.
- Review of CAPAs, Change Controls, and Defects for GxP applications.
- Working with Global teams and providing audit support.
- Working with a range of applications/tools including ALM, TrackWise, JIRA, Confluence, and other integration tools.
- 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.
- 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.
- • Medical, Vision, and Dental Insurance Plans
- • 401k Retirement Fund
Global Healthcare Innovator
- We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.
- Work on cutting-edge projects
- Contribute to global healthcare advancements
- Experience diverse cultures and geographies
- Client a rewarding career with a company that cares.
Salary : $1 - $40
