Software Quality Assurance

W. L. Gore & Associates has demonstrated a high-energy commitment to innovation over its 48-year history. Hundreds of products for demanding fabric, medical, electronic and industrial applications have grown out of our commitment to the creation of new, ever-better technologies. That spirit of innovation, challenge, and opportunity combines in a uniquely creative work environment and has contributed to Gore's repeated listing among the "100 Best Companies to Work for in America". Additional information is available about W. L. Gore on our website at www.gore.com



W.L. Gore & Associates is looking for a Software Quality Assurance professional to commit to a broad range of activities including, but not limited to the following; Creation of user requirements documentation, assessment of software applications for potential implementation in a regulated environment, verification and validation of computerized systems. Ensuring that quality system elements necessary to achieve and/or maintain compliance within an FDA/ISO regulated environment are established and activities related computerized systems are controlled via these elements. Preparation of software and hardware specification documents. Establishment of system quality expectations and performance metrics. Monitoring and interpretation of performance metrics. Preparation of and training to "Standard Operating Procedures". Implementation of corrective action measures, as required. Champion compliance projects such as 21 CFR Part 11 and GAMP. Gatekeeper of system change and configuration management activities and documentation. Preparation for and leadership of computer system audits, ensuring that Information Technology "Best Practices" are continuously applied and refined. Demonstrated experience with the following: ERP/MRP, MES, PLM, Software Quality Assurance processes, methods and requirements in an FDA/ISO regulated environment, including change management, configuration management and documentation.

Qualifications
The successful candidate will have a broad range of experience in a regulated industry, a desire to work in a dynamic team environment, be capable of generating quality and performance reports from metric data. Demonstrated project management and leadership skills. A four year degree in computer science, computer information systems, or technical field, or equivalent in combined education and experience is required. A minimum of three years of progressively responsible IT and QA experience is desired. Occasional travel may be required. Experience with the following is desired: Change Management Software, Configuration Management Software, Oracle, Visual Basic, MS Access, Sequel, Windows and UNIX platforms, LAN/WAN networks, Graphical User Interface Software, Client Server Software, Clinical Trials Software, Electronic Data Capture Software, Laboratory Information Management System Software. Excellent written and oral communication skills. Working knowledge of Verification and Validation methods. Ability to train others.



W. L. Gore & Associates, Inc. is an equal opportunity employer.
For further information regarding Gore, visit our website at www.gore.com