Senior Quality Specialist
Position Overview: In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Systems Specialist...
Position Overview: In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Systems Specialist...
under MDD/ MDR) for both regulatory agencies and distributors. Creates, reviews and approves change requests. Assist...
environment. Ensure projects are executed in compliance with regulatory requirements (GMP, ISO, MDD) & JJMT policy & procedure...
investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union...
, MDD 93/42/EEC and FDA QSR. Duties and Responsibilities: Review and develop process instructions for our products... operations in accordance with ISO 13485, MDD 93/42/EEC and FDA QSR. Duties and Responsibilities: Review and develop process...
management System, ISO 14971:2019 Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive...
requirements (GMP, ISO, MDD) & JJMT policy & procedure requirements. Excellent ability to convey complex technical information...
. This involves assuring quality standards (FDA, ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical Device requirements... Other duties may be assigned, in addition to those identified below Ensures FDA QSR (GMP), FDA OTC, ISO 13485, MDD, CMDCAS, MDR...
psychology and emerging medications to treat disorders such as MDD, GAD and PTSD empathetic and approachable...
processes. Prepare plans and documentation required to participate in the Material Development Decision (MDD), the pre-/post...