Wayne Mycko
Quality Specialist 3 @Philips
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WORK HISTORY
Quality Specialist 3 @Philips
Assist with the creation of IS Adverse Event Reports for International IS and Global markets•Review, correct and file MDR (Form 3500A) reports with the FDA to maintain compliance with 21CFR part 803•Provide weekly potential late reports to management•Develop, author and maintain reporting database and related documents•Compile data and submit monthly KPI reports to management documenting and tracking quality issues•Coordinate and submit FDA request letters for further information on compliant issues
EDUCATION
University of Massachusetts Lowell
Electrical Engineering
Massachusetts Bay Community College
Associate of Art degree, Liberal Arts
University of Massachusetts Lowell
Plastics Engineering Technology
SKILLS
ABOUT WAYNE MYCKO
Professional summary: Twenty five years of engineering experience in quality assurance, operations, test, validation, research and development in the Medical Device and Pharmaceutical IndustrySpecialties: • Knowledge of EtO and Gamma sterilization validation and operations, clean room design and operation• Extensive experience in all FDA, CFR, MDD, cGMP, ISO, EN standards.
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