Design Transfer Risk SME

Intellectt INCbullhead city, AZ

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Job Description

Hello,

I hope you're doing well.

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Design Transfer Risk SME based in Remote (EST) with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com

Role: Design Transfer Risk SMELocation: Remote (EST)

Summary: Mid-to-senior level (5 8+ yrs). Focused on risk within Design Transfer activities. Reviews transfer documentation through a risk lens and ensures manufacturing and production controls are appropriately risk-managed.

Key Responsibilities

Provide risk expertise specific to Design Transfer documentation
Review design transfer documentation for appropriate risk consideration
Support retrospective risk evaluation within transfer documentation
Assist in development of risk-based justifications for transfer gaps
Collaborate with Design Transfer workstream lead and Risk COE

Required Qualifications

Medical device risk management experience with focus on design transfer
Familiarity with ISO 14971 and QMSR risk expectations
Experience reviewing design transfer documentation with risk considerations
Experience in remediation initiatives in regulated environments

Thanks & Regards,• Vyshnavi Thuraka• Recruiter• Intellectt Inc • vyshnavi.t@intellectt.com• Direct: 732 204 6550• Desk number: 732 412 6999 - Ext: 225

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