US-MD-Gaithersburg: Software Quality Assurance
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Software Quality Assurance
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 (Product and non-product)including: o prepare protocols o review and approve protocols from other authors • Assist in design, development and maintenance of a Quality System compliant with cGMPs and ISO and other International regulations.
• 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. • Minimum of 5 years Software Quality Assurance experince required. • Experience working with the FDA and/or ISO auditors required.
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Team SQAFYI - Software QA Resource FYI