US-MD-Gaithersburg: Director, Software Quality To apply for this position, please visit this Website. http://sqa.fyicenter.com/jobs/99666833_Director__Software_Quality.html To see other opportunities, please visit http://sqa.fyicenter.com 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. Thank you, Team SQAFYI - Software QA Resource FYI http://sqa.fyicenter.com -- You received this message because you are subscribed to the Google Groups "Software Quality Assurance Center" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/software_qa_center?hl=en.
