Medical Device Quality Engineer (Risk)

Salt Lake City, UT

Job ID: 125797 Industry: Med
 
 

Medical Device Quality Engineer (Risk)

Environment:

Our client is a global medical device manufacturer. They develop and manufacture a number of   medical devices, primarily injectables and midline catheters. They are looking for a Quality Engineer to come and draft FDA Documentation, perform Risk Assessments and statistical analysis.

Scope of Work:

Our client seeks a candidate with a strong Quality Engineering background with Medical Device clients. This consultant will be well-versed in Risk Management as it pertains to both New Product Development and design changes. The client has identified a few issues around their Risk Management program and are looking to do a complete overhaul of their system and processes. The consultant must be comfortable working with a team of 5-7 FTE' s as well as other consultants.  They should have experience with both DFMEA and PFMEAs. Must be up to date on most current  ISO 13485 standards.

Required Experience:
  • Extensive Medical Device experience
  • Catheter experience
  • Risk Management
  • Quality Engineering experience
  • ISO 13485
  • Test Method Validation

Plus:
  • PIC Catheters
  • New Product Development

 

Job Type: Contract  

Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: