US-MD-Elkton: Quality Assurance Associate
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99679338_Quality_Assurance_Associate.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 09-Feb-2009



Quality Assurance Associate

This associate will work on cross-functional teams to address product
issues, define and implement effective corrective actions and monitor
post-implementation effectiveness. In addition, this associate will
focus on operational improvements; product development and design
control activities, systems enhancement (including software
implementation and validation), compliance auditing, vendor selection
and approval, and associate training. Further responsibilities may
include: initiation of change documentation; advisory roles supporting
various teams (such as raw materials inspection associates, document
control, maintenance and calibration, environmental monitoring and
control, etc.); preparation of quality reports; review of complaints;
and development of policies and procedures which affect operational
and compliance status.

Requirements Bachelor's degree in an applicable science or engineering
(or a two-year degree plus significant medical device experience or
significant medical device experience in a Quality Assurance role).
The successful candidate must have at least five years medical device,
pharmaceutical, or similarly regulated industry experience in quality
assurance or a related role. Additional demonstrated experience in the
following areas is also required: •Demonstrated excellent written and
oral communication skills •Strong interpersonal skills •Conflict
resolution skills •Quality System Regulations •Quality Systems
implementation and maintenance. The successful candidate must be able
to work independently, as well as part of a diverse team and must
possess the ability to set and meet aggressive timelines. Desirable
experience includes: working with vendor and process auditing, product/
process/software validation, generation of change control documents,
document control and receiving inspection. Additionally, familiarity
with ERP/MRP, MRS, and quality software systems (e.g., complaint,
document control, etc.) is a plus.



Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

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