· Strong engineering skills with working knowledge of product design, design verification, and product and process validation activities
· Strong data analysis skills. Ability to use problem solving techniques including root cause analysis and cause and effect analysis, Statistical techniques and methods.
· Good knowledge of statistical analysis and FMEAs
· Troubleshooting of production line issues
· Resolve quality issues according to company quality requirement
· Knowledge and familiarity with industry specifications/codes/standards
· Must have excellent verbal and written communication skills and able to effectively communicate with all levels of plant personnel as well as customers and suppliers.
· Must have experience in applying continuous improvement techniques as well as able to travel to supplier locations, as necessary.
· Experience in medical device quality control/assurance is preferred. Working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and risk management tools, such as, Risk Analysis, FMEA and FTA.
Best Regards,
Atul Sharma
IDC Technologies Inc. 1851 McCarthy Boulevard, Suite 116, Milpitas, CA, USA,- 95035,
Contact : 408-457-9399 EXT- 2070
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