Medical Device Design Assurance SME
Medical Device Design Assurance/Design History File SME
Our client is a leading supplier of medical devices. They are preparing to remediate their design history files and biocompatibility reports. They are in need of a Sr. Design Assurance subject matter expert to help with their risk documentation/work books. There will also be some work revolving around design FMEA.
Principle Duties and Responsibilities:
The consultant will be a Design Assurance/Design Quality Engineer from the medical device industry. The consultant must be comfortable hitting the ground running and rolling into a remediation effort atmosphere.The consultant will have an understanding of medical device regulations: ISO 13485, 21 CFR Part 820, ISO 14971. This consultant should have a long history of remediation efforts specifically with Design Assurance and design history files (DHF).
· Design Assurance/Quality background
· Medical Device background
· ISO 13485, 21 CFR Part 820, ISO 14971
- Remediation Experience
· Instrumentation experience
Job Type: Contract