US-DC-Baltimore: SOFTWARE QUALITY ENGINEER
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SOFTWARE QUALITY ENGINEER
This position is responsible for product and non-product software validation and risk assessment using guidance from U.S. and international guidance and standards. Assuring that software development is performed and documented using a software life cycle approach as well as supporting the development of regulatory submissions for products containing software are within the scope of this role. This position will also be responsible for facilitating the development, implementation and monitoring of software related quality programs, plans, SOPs and policies that ensure the development and maintenance of Quality System in compliance with corporate policies, GMP, FDA regulations, ISO 13485:2003, and other regulatory requirements as applicable.
A M.S. or B.S. degree in a technical/scientific/engineering discipline, with at least 7 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or a related industry are required. Experience working with the FDA and/or ISO auditors as well as new product submissions for products containing software is required. ASQ certification (CQE, CRE, CQA) is preferred. Candidates are expected to possess excellent working knowledge and experience of the FDA’s Quality System requirements (QSR), ISO 9001 and ISO 13485:2003 standards. Quality assurance experience in software is a plus. Candidates should possess the ability coordinate multiple projects and multi-task in an environment with changing priorities. Strong analytical, communication (linguistic, grammar, and editing skills) and interpersonal skills are a must. Proficiency with Microsoft applications (Word, Excel, Project, PowerPoint, and Outlook), and the ability to learn additional software applications as the need arises are a must.
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Team SQAFYI - Software QA Resource FYI