Processed focused person & detailed oriented approach with 6 years of depth work experience in document and change control and its management; Familiar with the different methodologies, databases and processes of change control management. Well versed with ISO 13485, 9001 and 17025 standard and developed initial QMS documentation for my past companies.
Execution of all Quality System activities to comply with relevant medical device regulations specifically ISO 13485:2003, FDA 21 CFR Section 820 & EC Medical Device Directive 93/42/EEC