Engineer II, Quality - Wayne, NJ
implementing changes to ensure compliance with all applicable QSR/ISO/MDD/CMDR/MDR requirements. Supports the creation...
implementing changes to ensure compliance with all applicable QSR/ISO/MDD/CMDR/MDR requirements. Supports the creation...
under MDD/ MDR) for both regulatory agencies and distributors. Creates, reviews and approves change requests. Assist...
Controls procedural requirements. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDD, EU MDR and other relevant... 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred...
that all activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP...), FDA and MDD regulations Ensure identification and reporting of safety issues (e.g. Adverse Events, Serious Adverse Events...
(CMDR), MDD 93/42 EEC and other applicable international medical device standards and regulations; Participate in problem...
. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD... for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations; Ensure identification...
with company policies, procedures and regulatory requirements (FDA, ISO, MDD, CMDR, etc.). Defines implements and monitors metrics...
and regulatory requirements (FDA, ISO, MDD, CMDR, etc.). Defines implements and monitors metrics for key indicators. Prepare...
conducts internal and external research studies and ensures these studies are compliant with Government Regulations (FDA, MDD...
complaints, the planning and execution of meetings and presentations. A working knowledge of GMP, ISO 13485 & MDD requirements...