SQAFYI - Software QA Resource - FYI

US-MA-Franklin: Quality Assurance Program Manager

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 26-Jan-2010

Quality Assurance Program Manager Minimum Education and Experience Requirements • Bachelor’s degree in Science or Engineering • Seven or more years as a QA professional. Experience in a CE/IVD or FDA regulated company preferred • Expert level knowledge of Quality System requirements, including ISO 9000 and/or ISO 13485 • Demonstrated experience coordinating multi-functional tasks and activities with various and differing departments and organizations. • Competent level of experience with Microsoft Office software (Word, Project, Excel, PowerPoint) • Familiarity with SAP or analogous Enterprise Resource Planning software systems, CAPA software systems, and quality improvement processes • A qualified auditor of ISO 9000 Quality Management Systems is preferred

Knowledge, Skills, and Abilities necessary to perform essential functions • Demonstrate excellent people skills including ability to probe with questions for information • Knowledge of specific standard requirements and their implementation (e.g., ISO, IEC, GMP, CE/IVD) and the ability to obtain and learn how to implement additional standards/requirements, as applicable • Demonstrate knowledge in a manner that helps others know how to comply with requirements – assist mode

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Thank you,
Team SQAFYI - Software QA Resource FYI

US-MA-Franklin: Quality Assurance Program Manager