appropriate change controls and documentation. Knowledge of regulations and standards (e.g.cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA...
knowledge in ISO standards and compliance (ANSI/AAMI ES-1, IEC62353, IEC60601-1, AS/NZS 3551) Experience within product testing...
of Health, TJC, OSHA, CDC, AAMI and AORN standards and facilities goals and policies. Coordinates and manages day-to-day...
as stated by (but not limited to) AAMI (Association of Advancement of Medical Instrumentation), AORN (Association...
and documentation. Knowledge of regulations and standards (e.g., cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA) Working knowledge of design...
by (but not limited to) AAMI (Association of Advancement of Medical Instrumentation), AORN (Association of Perioperative Registered Nurses...
processing standards (AAMI). Skills Knowledge of basic inventory control concepts. Follow guidelines for use of Personal...
of OSHA requirements, Quality Systems Regulations (QSR), Good Laboratory Practices (GLP), ISO, AAMI, and FDA Guidelines...
Qualifications Minimum of 3 years of experience as a BMET I or 5+ years of biomedical equipment experience AAMI certification...
, and decontaminates instruments, supplies and equipment according to hospital policies and procedures, AORN recommendations, AAMI...