Curtis Sizer
Life Science @Lyfmedics Ltd
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WORK HISTORY
Life Science @Lyfmedics Ltd
Open for opportunitiesContact:+49••••••••50
EDUCATION
Pikes Peak community college, Colorado Springs
Mechanical Design studies
University of Colorado
BSME studies, Mechanical Engineering
Metro state College
Bachelors studies, Science Mechanical Engineering
ABOUT CURTIS SIZER
Regulatory Affairs certification(RAPS University)• Sr. Project manager and Mechanical engineering manager with over 25 years of experience working experience with USA, Germany, Australia and China.• Gap evaluation, Validation and design of products across an extreme variety of products. Creation of technical files and technical summary evidence. • Possess 25+ years of Regulatory and Quality experience in a multitude of industries• Experience assessing QMS, ISO 13485: Including, DMR, DHF, and CAPA process improvement. Complete design and process remediation from Audit findings.• Experience with Risk management of ISO 14971 and IEC 60601-1/2 Equipment Qualification, IQ, OQ, PQ, dFMEA/pFMEA. • Periods of work in other highly regulated fields (Oil and Gas) mid-stream process plant pipe sizing and shell heat exchangers comply with Regulatory standard -ANSI, ISO, EPA, ASTM. • Knowledge in the medical device, hand held devices, mobile phones, test and measurement equipment, gas & oil midstream equipment, hard drive, and specialty connector industries (China).• Mother tongue, English and fluent in German.
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