What are the responsibilities and job description for the Quality Engineer - W2 only - hybrid, FL position at Chelsoft Solutions Co.?
Job Title: Software Quality Engineer (SQE)
Number of Positions: 1
Duration: 12 months
Work Location: Onsite - Hybrid (3 days a week)
Start Date: January
Project Details
Number of Positions: 1
Duration: 12 months
Work Location: Onsite - Hybrid (3 days a week)
Start Date: January
Project Details
- Scope of Work:
- Serve as SQE, working independently on supporting warehouse information
- Review test plans and requirement documents
- Perform approvals on documents to meet applicable regulations (21 CFR)
- Support validation on warehouse systems
- Support equipment decommissioning
- Collaborate on testing plans and approvals
- Work with supplier quality and commercial quality teams
- Day-to-Day Responsibilities:
- Review test plans and requirement documents
- Perform approvals to meet regulations (21 CFR)
- Support equipment decommissioning
- Collaborate on testing plans and approvals
- Work with supplier quality and commercial quality teams
- CSV experience in medical devices and 21 CFR (3-5 years, mid-level)
- GAMP 5 experience
- Experience in medical device manufacturing and operations
- GAMP 5 certification
- Onsite (local resource)
- CSQE certification
- Auditor certification
- Soft Skills/Company Culture: Team environment, collaboration, independent communication
- Education: Engineering/science/technical bachelor's degree
- Certifications: GAMP 5, Audit, CSQE (all are a plus)
- Experience Level: Mid (3-5 years)
- Industry Experience: Required in medical devices
