US-MD-Gaithersburg: Director, Software Quality
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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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Team SQAFYI - Software QA Resource FYI