Aditi Pillai
Senior Quality Engineer at Rook Quality Systems- Claim this Profile
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Experience
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Rook Quality Systems
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Senior Quality Engineer
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Oct 2022 - Present
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Quality Engineer
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Feb 2019 - Oct 2022
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Quality Engineering Intern
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Dec 2018 - Jan 2019
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University of South Florida
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United States
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Higher Education
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700 & Above Employee
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Graduate Research Assistant
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Aug 2017 - Aug 2018
• Performed calibration, testing, verification and validation of equipments and medical devices • Practiced and performed surgical procedures to implant rodents with temperature/pressure sensor • Designed optimal and well controlled clinical experiments and assessed the impact of body temperature, general anesthetics and tonometry on intraocular pressure • Analyzed the compiled data using statistical analyses and prepared statistical tabulations, graphs, abstracts• Developed corrective/prevention action plans for clinical experiments • Maintained accurate documentation of designs, processes, test protocols, test methods and data • Performed decontamination, assembling and sterilization of surgical instrumentation and equipment• Investigated new and advancing technologies for applications in biomedical products required during ocular surgeries• Maintained inventory of drugs and MSDS • Coordinated purchasing and assembly of components required as per clinical needs • Exposed to medical device regulations (ISO 13485, ISO 14971, ISO 9001, FDA 21 CFR Part 820) and regulatory submission requirements (510k)• Gained knowledge on cGCP, GMP, SOP’s and IQ, OQ, PQ validation• Maintained safe work environment in accordance with policies/regulations and maintained efficiency and quality of clinical procedures
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