's (CMS) Level-One and Level-Two Certifications *ASQ's ISO/IEC 17025 Compliance certification. *Familiarity with the...
regulatory standards (e.g. FDA or IEC). Review and approve system and subsystem requirement documents to ensure user needs...
development aligns to internal SOPs and IEC 62304, and working across departments to resolve issues. In particular, it will be the..., and manufacturability requirements. Maintains a deep understanding of IEC 62304. Partners with the electrical engineers to define...
development aligns to internal SOPs and IEC 62304, and working across departments to resolve issues. In particular, it will be the..., and manufacturability requirements. Maintains a deep understanding of IEC 62304. Partners with the electrical engineers to define...
standards (e.g., NIST, ISO/IEC). Integrate services with security capabilities in other domains. Develop and generate KRI/KPIs...
820, ISO 13485, IEC 60601, and other related external standards is a plus. Prior experience with initial design...
. Familiarity with functional safety standards (e.g., IEC 61508, ISO 13849). Proficient in automation programming languages (e.g...
within a Quality Management System. Strong understanding of regulations such as 21 CFR 820, ISO 13485:2016, and IEC 62304:2006. Hands... with key regulatory standards like ISO 13485, 21 CFR 820, and IEC 62304, furthering the candidate's expertise in the medical...
, hardware/systems design, and production under a Quality Management System Knowledge of 21 CFR 820, ISO 13485:2016, and IEC...
, and other international regulatory requirements and standards Experience with NRTL, NEC, NFPA, IEC, and CB Scheme and other safety...