Quality Assurance Engineer

Confidential Company  •  Philadelphia, PA

5 - 7 years experience  •  Medical Devices & Diagnostics

Salary depends on experience
Posted on 03/06/18 by Art Katz
Confidential Company
Philadelphia, PA
5 - 7 years experience
Medical Devices & Diagnostics
Salary depends on experience
Posted on 03/06/18 Art Katz

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%

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