Sr Quality Software Engineer in Myrtle Point

Job DescriptionJob Description

SWQA experience = Software Quality Assurance experience. It means experience ensuring medical-device software is developed, tested, documented, and released according to defined quality procedures and regulatory requirements. Typical SWQA work includes software verification & validation (V&V), test protocols/cases, requirements traceability, defect management, design controls, risk management, CAPA, and compliance with standards such as IEC 62304, ISO 13485, and FDA requirements.

510(k) submission experience means experience supporting or preparing an FDA 510(k) premarket notification for a medical device. The purpose of a 510(k) is generally to demonstrate that a device is substantially equivalent to a legally marketed predicate device. Experience could include preparing/reviewing software documentation, V&V evidence, risk-management documentation, cybersecurity documentation where applicable, device descriptions, performance-testing evidence, and responding to FDA questions.
eed SWQA experience + 510(k) submission experience

\nCompany Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.

Company DescriptionFounded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.