). Familiarity with system and software standards (ASME, IEEE, IEC, etc.). Familiarity with Documentum, Aconex, Enovia, Teamcenter...
with regulatory and compliance standards relevant to medical device software, including IEC 62304, ISO 13485, and the FDA’s General...
standards (e.g., INCOSE, ISO/IEC 15288). o Proficiency in modeling tools (e.g., SysML, Cameo, MATLAB). o Strong analytical...
:2018, and ISO/IEC 27001:2013. SMS is headquartered in McLean, Virginia, with offices and on-site operations at customer...
, EN, IEC. Prior project management experience. Experience working with control panels, switchgears, switchboards...
or exceed ISO/IEC, government regulatory (cGMP, GLP), and company requirements relevant to assigned duties. Additionally, the... to responsibilities such as Quality Manual, SOPs, and Methods. Adhere to quality measures to meet or exceed the standards set by ISO/IEC...
or exceed ISO/IEC, government regulatory (cGMP, GLP), and company requirements relevant to assigned duties. Additionally, the... to responsibilities such as Quality Manual, SOPs, and Methods. Adhere to quality measures to meet or exceed the standards set by ISO/IEC...
device industry, with a strong understanding of regulatory requirements (e.g., FDA 21 CFR Part 820, IEC 62304). Expertise...
, IEC 62304, and other global regulatory requirements and quality standards) Proven ability to learn and adapt to provide...
to deliver innovative products to market in accordance with FDA, ISO, and IEC standards. The ideal candidate has substantial... Quality System Regulations (21 CFR Part 820) & ISO 13485 Understanding of IEC 62304 and IEC 60601 standards Understanding...