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Start for FreeJohn Nachtigall
Advisor, Enterprise Compliance @Medtronic
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WORK HISTORY
Advisor, Enterprise Compliance @Medtronic
Las Vegas, NV, US
Support external regulatory inspectionsConduct mock external regulatory inspectionsProvide strategy and support for complex compliance situations enterprise wide
EDUCATION
Colorado School of Mines
BS, Metallurgy and Materials Engineering
Colorado School of Mines
MS, Metallurgy and Materials Engineering
SKILLS
ABOUT JOHN NACHTIGALL
Medical Device Quality Director with 25 years Medical Device industry experience regarding class II and class devices for domestic and international distribution. This includes more than 15 years of direct functional management experience. Expert in quality system design and execution both pre- and post-market. Strategically tackles and resolves complex (technical and regulatory) issues including 10 years of production experience, 8 years of direct remediation experience closing 483 observations, warning letters, and consent decrees and more than 12 years of new product development.Expertise:• Leading and participating in new product development at the quality, manufacturing, and R&D positions• Designing, enforcing, and using medical device quality systems compliant to FDA (CFR820) and international (ISO 13485, MDR) standards and including design control, process validation, and CAPA• Management of quality system personnel including influence of extended teams both pre- and post market• Leading teams and projects addressing remediation, recalls, complaints, warning letters, FDA actions, etc.• Corporate wide training to quality systems• Audit Management and Defense for both internal and external (MDSAP) sources• Risk Management; Quality Planning; SOP Development; Documentation; Process Improvements, Nonconformance Investigations
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