Responsible for ensuring that the software used as part of the company’s medical devices and products is developed according to good design practices nd procedures set forth by local, State and Federal regulatory authorities and notified bodies. This also includes providing 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.
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 - Working knowledge of product risk assessment - Management and tracing defect tracking configuration management techniques and how they are applied in the software development lifecycle - Understanding current 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 - Understanding of the FDA Quality System Regulation ISO 13485 quality standards, and Medical Device Directive a plus but not required .
• EDUCATION: Bachelor of Science degree in Electrical Engineering Computer Science or Computer Engineering
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