|Recruiter Name:||Sumit Gupta|
|Job Posted On:||07-09-19 (08:10 PM)|
|Location:||1 Millennium Way, Somerville, NJ, 08876|
Scope of Work:
Consultants will provide hands-on expertise to revise and document the Quality Management System, Clinical, Post-Market Surveillance, and Supplier Management processes as necessary for compliance with the European Union Medical Device Regulations (EU MDR). In addition, medical device technical files will be reviewed to ensure use of prohibited hazardous substances are in accordance with the limits set forth in the General Product Safety Requirements (Annex I), and records will be created as necessary to fulfill the requirements of the various Annexes.
Education & Qualification Requirements:
Minimum of a Bachelor’s Degree is required, with preference for natural sciences or engineering.
5+ years’ experience in Medical Device Quality Systems and/or Quality Assurance.
Experience with Documentation Control and Change Control.
First-hand experience with implementation of EU MDR requirements.
Strong technical writing skills.
Skills & Keywords :-
Electro-mechanical, analog & digital debug and trouble-shooting, Test fixture project management, test automation, automated test equipment and software using C #, Visual Basic, Visual C++, Perl scripting. Powershell, Labview, LabWindows and/or TestStand