drjobs Quality Assurance and Regulatory Affairs QARA

Quality Assurance and Regulatory Affairs QARA

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Job Location drjobs

Alexander City - USA

Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Job Description

Quality Assurance and Regulatory Affairs (QARA)

Skillset: QARA creation of DIOM matrix to identify the gaps in DV test as per the current regulatory standards

Client is looking for a vendor to create/update the Design control Document and make recommendation on gaps in Design Verification.

This will include reviewing the historical data and documents.

The client seeks support on system engineering risk management and quality engineering to align the existing technical documents with the current regulatory standards.

A gap analysis of existing data for Class I devices write system requirements user needs creation of DIOM matrix to identify the gaps in DV test as per the current regulatory standards.

The end goal for Client is to have a good DHF (Design History File) document for final regulatory submission.

Employment Type

Full Time

Company Industry

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