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...
to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD...
Role Descriptions: Design| Configurations Development using Opcenter EX Core MDD Semi Electronics Hands on experience...
in a medical device discipline GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971...
, 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...
operations typical ofthe following: blending of multiple adjacent MDD surfaces intoengineering tolerances and/or perform...
. Experience working under regulated quality systems such as GMPs, ISO 9001, and the MDD. Demonstrated knowledge of Design Control...
and Skills: Quality Management Systems requirements for medical devices Knowledge and applied experience of 21CFR, MDD 93/42...
Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971, EU MDD/IVD, EU MDR/IVDR, SOR/98-282, TG(MD)R, RDC 16, Ordinance #169...