Technical Operations Specialist III (Onsite)
to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD...
to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD...
, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. This position... medical device industry Min 8 years auditing per ISO and/or FDA standards. Knowledge of MDD, CMDR, MHLW, TGA, ANVISA...
Descriptions: Design| Configurations Development using Opcenter EX Core MDD Semi Electronics Hands on experience on Designer| Portal...
in a medical device discipline GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971...
and Skills: Quality Management Systems requirements for medical devices Knowledge and applied experience of 21CFR, MDD 93/42...
operations typical ofthe following: blending of multiple adjacent MDD surfaces intoengineering tolerances and/or perform...
Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971, EU MDD/IVD, EU MDR/IVDR, SOR/98-282, TG(MD)R, RDC 16, Ordinance #169...
. Experience working under regulated quality systems such as GMPs, ISO 9001, and the MDD. Demonstrated knowledge of Design Control...
such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. Expert knowledge of GMP, GDP procedures...
’s (SSP), Multi-Department Direction’s (MDD), and Single Department Direction’s (SDD). * As a SSW you will maintain...