US-CA-Irvine: Manager Software Quality

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.

To apply for this position, please visit this Website.

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