My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Manufacturing QA Specialist 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

Role: Manufacturing QA Specialist
Location: Remote (EST)

Summary:
Mid-to-senior level (5 8+ yrs). Provides QA review with a focus on manufacturing and design transfer documentation. Experience with manufacturing quality systems and design transfer in a regulated MedDev environment required.

Key Responsibilities:

• Perform QA review of design transfer and manufacturing-related DHF documentation
• Assess documentation for completeness, traceability, and regulatory compliance
• Identify documentation gaps and quality risks in manufacturing documentation
• Provide review comments and recommendations to remediation teams
• Support cross-functional remediation workstreams as needed

Required Qualifications:

• QA experience in regulated medical device manufacturing environments
• Experience with design transfer, process validation, and manufacturing documentation
• Experience supporting remediation initiatives in regulated environments
• Familiarity with design controls and DHF documentation
• Strong document review and compliance assessment skills

Thanks &