Run tests and ensure that software for medical devices and products is developed according to good design practices and follows the corresponding requirements set forth by local procedures regulatory authorities and notified bodies.
Will provide oversight and training to division manufacturing plants for computerized system validation and translating quality standards into processes and procedures and applying them to the design process.
Requirements: 1+ years in a software quality engineering or software test role dealing with software that is part of a medical device or a product for a highly regulated industry (i.e. aerospace automotive etc.)
Working knowledge of product risk assessment requirements management and tracing defect tracking configuration management techniques and how they are applied in the software development lifecycle
Understanding Software Quality techniques and software industry standards (e.g. ISO IEEE CMMI) and their impact on internal procedures software quality safety and efficacy of products
Working knowledge of understanding FDA Quality System Regulation and Medical Device Directive a plus but not required All inquiries and resumes will be kept in strictest confidence
Recent grads with one or two internships, where intern worked on actual projects, and gained work experience in project planning, development and delivery, compensation will depend on level of experience.
• EDUCATION: Bachelor of Science degree in Electrical Engineering Computer Science or Computer Engineering
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