Level 3 and ISO 9001: 2015, ISO/IEC 20000-1:2011, ISO/IEC 27001:2013, ISO 14001 Certified Small Disadvantaged Woman Owned...
. Proficient knowledge of quality standards: ISO 9001, ISO 13485, IEC 62304, ISO 11137, 21CFR Part 820 and other appropriate...
-1.001 to 60GG-1.009, F.A.C.) and ISO/IEC 20000 standards. Must-Have: PMP Certified from PMI Well-versed in Cloud Migration...
UL, CSA, IEC, ANSI, and OPEI. More critical is the identification of safety risks outside of the scope of existing...
instrumentation Assist with updating SOPs as needed to ensure compliance Perform IDL, IEC, linear range, and MDL determinations...
Level 3 and ISO 9001: 2015, ISO/IEC 20000-1:2011, ISO/IEC 27001:2013, ISO 14001 Certified Small Disadvantaged Woman Owned...
/firmware development and technologies Working knowledge of medical device standards such as ISO 13485, ISO 14971, IEC 60601-1..., IEC 61010-1, IEC 62304, etc. Here are a few of our preferred experiences… Experience using requirements management...
, information security and IT operations. Knowledge of common information security management frameworks, such as ISO/IEC 27001...
and combination products (e.g., FDA/CDER human factors guidance, FDA/CDRH human factors guidance, IEC 62366, HE 75, guidance for OTC...
meetings. Must be or become a member of construction associations such as ABC or IEC. Skills: Excellent communication...