What are the responsibilities and job description for the Software Quality Engineer position at GTT, LLC?
Job Title: Software Quality Engineer
Location: Lake Forest, IL
Duration: 12-month Contract
Work Type: Onsite
Pay Range: $37.41/Hr
Key Responsibilities:
Minimum Qualifications:
Preferred Qualifications:
Benefits:
About The Company:
Global Healthcare Innovator
24-15198 #gttjobs #LI-GTT #LI-Onsite
Location: Lake Forest, IL
Duration: 12-month Contract
Work Type: Onsite
Pay Range: $37.41/Hr
Job Description:
Are you a skilled Software Quality Engineer with a passion for ensuring product excellence in a regulated environment? Join our dynamic team in Lake Forest, IL, to contribute to the development and maintenance of critical GxP applications.
Key Responsibilities:
- Quality Assurance: Rigorously review and approve software lifecycle deliverables, including risk classifications, requirements, design specifications, IQ/OQ/PQ validation documentation, trace matrices, and summary reports.
- Compliance Expertise: Collaborate with cross-functional teams to build robust compliance capabilities, ensuring adherence to FDA regulations (21 CFR Part 11, 820, Annex 11) and other industry standards (GAMP5, ISO 13485, ISO 27001).
- Defect and Change Management: Review and analyze CAPAs, change controls, and defects for GxP applications to identify root causes and implement corrective actions.
- Global Collaboration: Work seamlessly with global teams to provide audit support, ensuring compliance with international regulations and standards.
- Tool Proficiency: Leverage your expertise in ALM, TrackWise, JIRA, Confluence, and other integration tools to streamline quality processes and enhance efficiency.
Minimum Qualifications:
- Bachelor's degree in Computer Science, Engineering, or a related field
- 8 years of experience in software quality assurance, with a strong focus on GxP systems
- In-depth knowledge of FDA regulations, including 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485, and ISO 27001
- Proficiency in quality management tools (TrackWise, ComplianceWire, Veeva) and test management tools (ALM, JIRA)
- Experience with data integrity principles and audit support (internal and external)
- Strong understanding of cloud technologies (SaaS, IaaS, PaaS) and their application in regulated environments
Preferred Qualifications:
- Master's degree in a relevant field
- Experience with custom software development and commercial-off-the-shelf (COTS) applications
- Strong problem-solving and analytical skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About The Company:
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.
24-15198 #gttjobs #LI-GTT #LI-Onsite
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