US-CA-Irvine: Manager Software Quality
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99662863_Manager_Software_Quality.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 24-Jul-2012

Manager Software Quality

* Develop, maintain, and improve software quality processes to assure 
compliance with worldwide regulatory requirements.

* In conjunction with IT management, evaluate and determine strategic plan 
for implementing computer systems globally following the GAMP5 SDLC 
approach. * Manage the work activities and development of a staff of 
software quality engineers and supervise validation consultants * 
Participate in software validation planning, development and execution 
activities as required * Partner with global remote EW sites to build SWQA 
and Software Validation expertise in order to support regional system 
implementations

* The Manager, Software Quality role requires a minimum of seven years 
experience as a quality professional, preferably within medical devices, 
with at least one year of experience managing exempt level resources. 
Experience in software validation within a regulated environment is 
required. * A bachelor's degree in a science, engineering or IT discipline 
is required. * Strong time management skills, good documentation practices 
and communication skills are required. * Direct and matrixed supervisory 
experience, strategic thinking and problem solving capability is required. 
Ability to influence others at all levels of the organization is essential. 
* Understanding of FDA, including 21CFR Part 11 regulations,ISO regulations 
and software metrics is highly preferred. Well-versed in program and 
project management, and new product development best practices is preferred.


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

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