· Set up and maintenance of ISO based Quality Management Systems.
· Application of Statistical Techniques such as: DOE, SPC, Cp & Cpk, GR&R and Statistical sampling.
· Assistance in compiling and analyzing the data using statistical and problem solving tools.
· Assistance in Medical Device qualification/validation processes (Risk Assessment, IQ,OQ,PQ).
· Assistance in CE Marking for Medical Device (93/42/EEC) and In Vitro Diagnostics (98/79/EEC) products.
· Facilitate improvement project through Six Sigma methodology.
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