What are the responsibilities and job description for the QA Specialist III position at CorTech?
Shift Timings: 8:00 AM to 5:00 PM
This position is Non Exempt. Hours over 40 will be paid at Time and a Half. Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree and/or 5 years equivalent experience
This QA Specialist III position will be responsible for supporting processes within the Field Quality team in the Molecular Diagnostics Division of Client . We are looking for a highly motivated professional with experience in quality compliance and a successful track record in the global regulated medical device environment. An excellent candidate has: • Knowledge & experience working in FDA code of Federal Regulations, specifically CFR 21 Part 803 and 806, ISO 13485, MDSAP, EUMDR and IVDR environments. • Experience related to the evaluation of potentially reportable adverse events and reporting of adverse events to appropriate agencies is required. • Experience with FDA e- submitter & Web Trader • Excellent skills in the areas of leadership, communication, teamwork, problem solving, analytical, organized, strategic thinking, time management, multi-tasking and technical writing.
This position is Non Exempt. Hours over 40 will be paid at Time and a Half. Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree and/or 5 years equivalent experience
This QA Specialist III position will be responsible for supporting processes within the Field Quality team in the Molecular Diagnostics Division of Client . We are looking for a highly motivated professional with experience in quality compliance and a successful track record in the global regulated medical device environment. An excellent candidate has: • Knowledge & experience working in FDA code of Federal Regulations, specifically CFR 21 Part 803 and 806, ISO 13485, MDSAP, EUMDR and IVDR environments. • Experience related to the evaluation of potentially reportable adverse events and reporting of adverse events to appropriate agencies is required. • Experience with FDA e- submitter & Web Trader • Excellent skills in the areas of leadership, communication, teamwork, problem solving, analytical, organized, strategic thinking, time management, multi-tasking and technical writing.
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