SQAFYI - Software QA Resource - FYI

US-TX-FortWorth: Software Reliability QA

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Date: 21-Apr-2015

Software Reliability QA

Works with minimal guidance to support R&D in the design and development of software used in, or in support of, Alcon products, services and/?or laboratory equipment.? Contribute to the processes and tools used to create and test software applications.? Develop and assess the quality programs and systems of Alcon to applicable GxP regulations and internal standards.?

• Lead the Software Reliability QA function to ensure systems are in place to satisfy regulatory requirements.? • Maintain and ensure compliance with quality programs, policies, processes, procedures, and that the performance and quality of products conform to established standards, specifications and agency guidelines.? • Develop, analyze and monitor metrics pertaining to software defects detected during development, inspection, testing, verification and validation.? • Provide expertise and guidance in interpreting policies, regulatory and /?or governmental regulations and agency guidelines to assure compliance.? • Recommend and lead corrective and preventive actions to improve software product quality.? • Ensure documentation and findings are completed on time and in a timely manner in accordance with applicable agency standards and procedures.? • Work independently to determine and develop solutions that are consistent with organizational objectives.? • Provide QA oversight to assigned projects.? • Represent R&D QA as the prime technical contact on applicable initiatives.?

• Education-Bachelor's in a scientific/?technical discipline.? • Fluent in English.? • Working knowledge of GLP, GCP, GMP, FDA Quality System Regulations, EU Medical Device Directive, ISO 13485, ISO 14971, ISO 62304 standards and FDA Guidance Documents related to Software Validation and Software Use in Medical Devices • 9-13 year’s applicable experience, three of which preferred in the pharmaceutical or medical device industry.?

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Thank you,
Team SQAFYI - Software QA Resource FYI

US-TX-FortWorth: Software Reliability QA