US-CO-Broomfield: Software Quality Engineer
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Software Quality Engineer
The Software Quality Engineer will be responsible for Quality Assurance processes, including internal audits, quality reviews, and a controlled documentation system throughout the organization.
Experience: • Prior experience in an CLIA/FDA Regulated environment • Ability to gather requirements from stake holders and turn them into formal engineering specifications • Ability to create verification and Validation Protocols from engineering specifications • Familiar with Black and White Box testing techniques • Familiarity with formal risk analysis techniques and Failure Modes and Effects Analysis (FMEA) • Perform Requirements Traceability – Preferably using Rational RequesitePro • Familiarity with ISO 14971 • Familiarity with ISO 13485 • Familiarity with HIPAA and HITECH regulations • Ability to read/understand JAVA and C#, for performing white box testing and code reviews • Exposure to any LIMS • Familiarity with relational databases, preferably MySQL for SQL queries and performing backups • Good understanding of Windows XP, Vista, Server 2003, Windows 7 operating systems and networking principles • Good understanding of computer systems (MS Office, SharePoint 2007/2010)
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