Manufacturing Supervisor, Production (Plasma Products)
for ensuring that production processes and employees comply with regulatory standards (FDA, cGMP, ISO13485, MDD and Country-Region...
for ensuring that production processes and employees comply with regulatory standards (FDA, cGMP, ISO13485, MDD and Country-Region...
of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR. Experience...
9001, and the MDD. Familiar with Design Control procedures and requirements. Demonstrated excellent written and verbal...
global, federal, and local regulations, including RoHS, REACH, WEEE, Proposition 65, EU MDD, and EU MDR. You will influence...
and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge / Experience developing ways of accomplishing goals...
treats a variety of diagnoses such as Major Depressive Disorder (MDD), Bipolar Disorder, Schizophrenia, Borderline...
of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) You will have good...
Practices), FDA, ISO 13485 and compliance regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge...
13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR) Able to travel up to 10% of the time...
Standards, MDD and MDR. Knowledge of statistical analysis and design of experiments (DOE) preferred. Knowledge of Computer...