Tampa , FL , United States
Provide leadership 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.
The Software Quality Engineer responsible for ensuring that the software for medical devices. Develop products according to good design practices and follows the corresponding requirements set forth by local procedures regulatory authorities and notified bodies.
Requirements: 3+ 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 C C++ and LabVIEW Understanding of the FDA Quality System Regulation ISO 13485 and Medical Device Directive a plus but not required. All inquiries and resumes will be kept in strictest confidence
Company may also consider recent grads with one or two internships, where person worked on where intern worked on actual projects, and gained work experience in project planning, development and delivery
• EDUCATION: Bachelor of Science degree in Electrical Engineering Computer Science or Computer Engineering
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