Matthew Avioli
Quality Engineer @Onkos Surgical
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WORK HISTORY
Quality Engineer @Onkos Surgical
Parsippany, NJ, US
Onkos Surgical was founded in 2015 with a focus on sarcoma and other rare, complex cancers of the musculoskeletal system. Onkos’s ISO 13485/FDA/UK compliant technology is revolutionizing how musculoskeletal cancer and complex orthopedic conditions are treated.Assisting the resolution of CAPAs and revising SOPs/Work Instructions.Involved in a SOP update of the Recall/Market Withdrawal process.
EDUCATION
Brandeis University
Bachelors of Science, Biology, Anthropology
Fairleigh Dickinson University
M.B.A., Pharmaceutical Management Concentration
ABOUT MATTHEW AVIOLI
Experienced FDA 21 CFR 820 EU MDR MDSAP ISO 9001 ISO 14971 ISO 13485 CAP CLIA IVD/LDT Quality Engineer seeking QA/QC management role within the biotech, pharmaceutical, cosmetic, chemical industry. With 19+ years of IVD/LDT (FDA Class QA/QC experience, along with experience in aseptic pharmaceutical manufacturing compliance and human skin culture research experience in the cosmetic industry. Expert in GMP/ISO equipment qualification, nonconformance, deviations, change management, design controls, and CAPA/remediation. Experienced at leading and applying risk management tools to ensure high levels of patient and customer safety.
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