US-CO-Boulder: Senior Software Quality Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 09-Jun-2008

SUMMARY OF POSITION:

Responsible for ensuring that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to division manufacturing plants for computerized system validation. Best Practices - Translate standards into processes and procedures and apply these to the design process

ESSENTIAL FUNCTIONS: 1. Promote a structured software development process. Assure that a state of control is maintained for in-house and outsourced software development. 2. Participate in critical analysis, design, and change review meetings for product and non-product software. 3. Provide oversight of manufacturing software validation process. 4. Generate metrics for assessing software quality and evaluate results. 5. Contribute to process improvements by developing and/or updating written company or departmental procedures related to software development. 6. Administer configuration control system for device, manufacturing and product development tools software. Provide oversight during software release to manufacturing as well internal distribution. 7. Administer and control problem-tracking database and oversee defect process resolution. 8. Support outsourced software vendor audits and qualification. 9. Provide software validation, design controls, and risk management training.

Minimum Requirements: Bachelor of Science degree in Electrical Engineering, Computer Science, or Computer Engineering 5+ years in software quality engineering role dealing with embedded software that is part of a medical device. Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products Working knowledge of C, C++, and LabVIEW

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com