SQAFYI - Software QA Resource - FYI

US-MD-Gaithersburg: Director, Software Quality

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Date: 29-Sep-2011

Director, Software Quality

Responsibilities Development and maintenance of software Quality Assurance procedures Product and non-product software Quality Assurance including software development lifecycle and validation. Support new product submissions for products containing software. Review and/or perform software validations including:preparing protocols as well as reviewing and approving protocols from other authors Assist in design, development and maintenance of a Quality System compliant with cGMPs and ISO and other International regulations.

Position Requirements BS or MS degree in technical/scientific/engineering discipline Minimum of 8 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or a related industry. Experience working with the FDA and/or ISO auditors required. Experience with new product submissions for products containing software required. ASQ certification (CSQE, CQE, CRE, CQA) is preferred. Excellent working knowledge and experience of FDA's Quality System requirements (QSR),ISO 9001 and ISO13485:2003 standard. QA experience in software required. Ability to coordinate multiple projects.

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Thank you,
Team SQAFYI - Software QA Resource FYI

US-MD-Gaithersburg: Director, Software Quality