Overview
On Site
Full Time
Skills
Quality Assurance
Warehouse
Test Plans
Testing
Science
Computerized System Validation
Medical Devices
Manufacturing
GAMP
Collaboration
Communication
Job Details
Responsibilities:
- 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.
- 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.
- Engineering/science/technical bachelor's degree.
- 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.
- uditor certification.
- Team environment, collaboration, independent communication.
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