with internal and external audiences Specialized Knowledge: Knowledge of current FDA, ISO, MDD, and other related quality...
). Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements...
, and the MDD Familiar with Design Control process Excellent written and verbal communication skills Proficiency...
. Applicable Regulatory and Industry standards (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971,ISO 10993, etc.)Quality Engineering...
to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. Ability to detail... (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations. Experience working with ERP/MRP...
systems designed to meet governmental regulations such as FDA, GMPs, QSR, ISO 13485/9001, and the MDD. Experience leading...
responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation...
. Experience working under regulated quality systems such as GMPs, ISO 9001, and the MDD. Demonstrated knowledge of Design Control...
(FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry Experience with design verification...
, MDD, MDSAP, ISO and any other regulatory requirements as assigned. Identify, prioritize and drive continuous improvement...