Requirements Management, Sample Size Determination, Design and Usability, Statistical Methods, Risk Management, Rca, 21 CFR Parts 820, Audit Process, fault tree analysis, EU MDR, Safety Risk Management, ISO14971, MEDDEV, ISO13485

materials testing , Microsoft Excel, materials laboratory sourcing

statistical concepts , Quality System Regulation, Iso 14971, design of experiments, FDA 21CFR820, ASQ certified quality engineer CQE, Design Control principles, Risk management activities, Six Sigma Methodology, ISO13485

statistical concepts , Design Control principles, Continuous Improvement, Iso 14971, Six Sigma Methodology, Risk management activities, ISO13485, design of experiments, quality engineering, FDA 21CFR820, Quality System Regulation, measurement system analysis

TS, in-process metrology, Qs, Fmea, electrical connector part functions, Spc, Volume Graphics, dimensional control principles, plastic manufacturing processes, IATF 16949, design of experiments, Calypso, APQP, 2D tolerance analysis, Six Sigma Tools, CT scanning, Internal Auditing, Msa, measurement software

IATF6949 Lead Auditor, materials characterization methodologies, materials specification, FMEA development, Six Sigma Greenbelt certification, structured problem solving, 8D analysis, ISO9001-2015 Internal Auditor

Software Quality, Agile Methodologies, Iso 13485, TGA, Production and Process Controls, IEC 62304, Software Hazards Analysis, EU MDR, 21 CFR 820, Capa, FDA QSR, Iso 14971, MDSAP, Design Controls, Post-Market Vigilance, Complaint Handling, Health Canada

TS, in-process metrology, Qs, electrical connector part functions, Fmea, Spc, Volume Graphics, IATF 16949, plastic manufacturing processes, dimensional control principles, design of experiments, Calypso, APQP, 2D tolerance analysis, Six Sigma Tools, Internal Auditing, CT scanning, Msa, measurement software