Quality Assurance Engineer

  •  

Philadelphia, PA

Industry: Medical Devices & Diagnostics

  •  

5 - 7 years

Posted 283 days ago

  by    Art Katz

This job is no longer available.

A very fast growing medical device company needs a Quality Assurance Engineer at their headquarters located in a desirable suburb of Greater Philadelphia, PA. Relocation assistance is available.

MUST HAVES:

-BS or BA in a related field 

-Minimum of 5 years' QE success in FDA and ISO regulated quality system 

-Experience in medical device manufacturing quality

-Proven knowledge of ISO 13485 standards and 21 CFR 820 regs 

-Must possess excellent expertise in CAPA process, including the optimization of CAPA system architecture 

-Ability to ensure risk management activities and CM?s are consistent with EN ISO 14971:2012 

-Expertise with computer software including MS Office, Adobe, NetSuite and Sharepoint 

-Willingness to travel 10-15%