Consultant, Quality Engineer, Design History Files/Design Controls, Medical Devices

Summary

Our client, a rapidly growing medical device firm, has engaged GForce Life Sciences to provide a quality engineer to join their team and will be responsible for the design history file review effort by performing a full gap analysis of the design documentation of on-market legacy products.

Duties / Expectations of Role

·Responsible for collecting and assessing existing design documents, and to perform a gap analysis of the DHF/Design documentation based on current regulatory agencies' guidelines regarding design control.

·Responsible for drafting remediation protocols in order to complete and/or correct design documentation.

·Responsible for organizing an electronic repository and presenting it to appropriate Subject Matter Experts in order to assume a proper knowledge transfer.

·Assist with collection of existing design control documentation and establish an electronic repository...