Staff Quality Assurance Engineer
820, ISO 13485, 14971; IEC 60601-1, IEC 62304 medical device software, cybersecurity, and related regulations Experience...
820, ISO 13485, 14971; IEC 60601-1, IEC 62304 medical device software, cybersecurity, and related regulations Experience...
or above of professional work experience in a process engineering or quality function in the solar industry Familiar with ISO 9000 and IEC...
industry Risk Management per ISO 14971 preferred Medical device software development per IEC 62304 preferred ISO 13485...
Requirements, ISO 14971 Risk Management Standard and IEC 62366 Application of Usability engineering to medical devices, EN60601...
Insurance, and 401k matched. SkyePoint Decisions is an established ISO 9001:2015 and ISO/IEC 27001:2013 certified small...
per ISO 14971 Medical device software development per IEC 62304 preferred Background in machine learning, digital image...
experience, QSR/ISO regulations (e.g., ISO 13485, IEC 62304) & standards and risk management (ISO14971). Excellent problem...
standards (e.g., NIST, ISO/IEC). Integrate services with security capabilities in other domains. Develop and generate KRI/KPIs...
for a project and make preliminary recommendations Assist in performing systems engineering activities in the ISO/IEC 15288...
, Woman, and Minority-Owned Business Enterprise, ISO/IEC 27001, SOC 2 Type 2 certified company with massive 18+ years...