, ISO 14971 IEC 60601 series. Knowledge of Good Documentation Practices (GDP). Good analytical and organizational skills...
devices and applications Understanding of IEC 60601 standards Preferred qualifications: Master's or PhD in Electrical...
-level electronic components, including cable assemblies in accordance with medical device regulatory standards (IEC-60601... Experience with medical device development, manufacturing, and regulatory compliance preferred (IEC 60601, ISO 13485, ISO 14971...
in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2017. PCI is an FCX Performance Company and a Subsidiary... in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2017. PCI is an FCX Performance Company and a Subsidiary...
.A.C. Experience with ISO / IEC 20000 Information Technology Service Management Experience with MS Office Suite, MS...
compliance per IEC 61326-1 or similar, including test approach/strategies Design for electrical safety compliance per IEC 61010... 14971 for product risk management Specific medical device electrical safety standards and EMC standards: IEC 60601-1...
), Innovation and Entrepreneurship Center (IEC), and the Business Management Office (BMO) as part of the IPO Leadership team...
System Regulations (QSR), REACH and RoHS directives, and medical device standards (i.e. IEC 60601) as applicable...: 3.0 or higher is preferred Working knowledge of medical device and similar safety standards (i.e. IEC 60601-1, IEC 61010-1...
System Regulations (QSR), REACH and RoHS directives, and medical device standards (i.e. IEC 60601) as applicable...: 3.0 or higher is preferred Working knowledge of medical device and similar safety standards (i.e. IEC 60601-1, IEC 61010-1...
competency (IEC 61511, PHA, PSSR, etc.) Ability to identify and implement optimal instrumentation testing and calibration...