Kyle Kramer

Background

About Kyle Kramer

Quality Assurance Leader with diverse skills in Production Controls, Continuous Improvement, Design Controls, Risk Management, Post Market Surveillance and Quality Management Systems Comprehensive understanding of 21 CFR 820 and ISO 13485 requirements, capable of driving problem solving that promotes patient safety while meeting regulatory requirements and business expectations. Servant and relationship-oriented leader with a demonstrated ability to energize, develop and empower high-performing teams towards organizational objectives. Knowledge and Skill Sets: • Quality Systems – ISO 13485, 21 CFR 820, 21 CFR 803, ISO 14971, CAPA, NC, Management Review, Internal/External Audit, Document Control, Training, Supplier Controls, Post-Market Surveillance, Supplier Controls & Design Controls Process Ownership • Production Controls – ANSI/ASQ Z1.4-2003, ANSI ASQ Z1.9 Sampling Plans, Statistical Process Control (SPC), Process Validation & Test Method Validation • Quantitative Methods- Process Capability Analysis, Hypothesis Testing, Design of Experiments, Statistical Decision Making • Continuous Improvement – Pareto, Value Stream Mapping, Lean Six Sigma, CAPA, Root Cause Analysis • Design Controls – Design Verification, Design Validation, Process, Design & Usability FMEAs, • Post Market Surveillance- Complaint Investigations, Complaint Intake & Reporting, FDA Additional Information Requests, Health Hazard Evaluations and Recall Determination • Proficiency in Agile PLM, SAP, Minitab, Compliance Wire, Microsoft Office. • High Performance Team Building & Talent Development