US-CA-Irvine: Manager Software Quality
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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.
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Team SQAFYI - Software QA Resource FYI