🚀 go-pugleaf

To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99898757.html
To see other BioTech job opportunities, please visit
http://biotech.fyicenter.com/
Date: 29-Jun-2006



Quality Engineer

Responsible for all quality system activities in support of the
Repository Operations and Commercial Services. Assures compliance to
Corporate policies and procedures, regulatory, FDA QSR guidelines,
customer requirements and potentially ISO. Assists in goal setting and
reporting on the effectiveness of the quality system. Champions the
primary quality system functions: (1) Corrective and preventive
actions, (2) records, documents and change control, (3) material
controls, (4) design controls, (5) equipment and facility controls, and
(6) production and process controls.

Requirements: Qualified applicants will have a Bachelors degree in a
technical/scientific discipline plus related experience in the medical
device, in vitro diagnostics or life sciences industry; 2+ years
experience with production and process controls; knowledge of FDA
Quality System requirements and corrective action; ASQ - Certified
Quality Engineer preferred. Experience interpreting and complying with
CLIA, IVDD or MDD and working knowledge of ISO 13485 and the
certification process. Must be willing to travel between Gaithersburg
and Frederick locations when necessary.



Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/