Enqual LLC provides consulting services, primarily in the medical device industry. We help in managing change in the medical device arena for New Product Development and Quality Management Systems optimization. Offering team leadership as well as a blend of mechanical and quality engineering services towards the goal of regulatory compliance. I am capable of leading change through leadership, mentoring, and coaching in the following areas. • R&D Quality Process Excellence (DFSS & DMAIC & LEAN) • Quality Management Systems Improvement • 21 CFR 820, ISO 13485, AND ISO 14971, ISO9000/9001 • Design assurance through Systems development management • Test method development • Corrective/preventive action • CAPA COACH Request to initiate CAPA, Correction Plan, Problem Investigation, Determination of Root Cause, Action Planning, Verification of Action, Action Implementations, and Effectiveness Check. • Root cause analysis • Design of experiments (DOE) • Gage R&R • Statistical analysis • DHF remediation PMHA, CEA (clinical effects assessment), regulatory trace tables, targeted design/process trace tables, and targeted assessment summaries. • Product Development Assess sensitivities of blood samples to electro-mechanical actions automated blood analyzers Brainstorming activities Design advice • Support projects towards 510k submissions • Ensure robust Validation and Verification plans • IQ/OQ/PQ documents. • Create and Support the device history file (DHF), device master record (DMR) and device history record. • Risk management support • Facilitating (Process) (Design) (User) FMEAs and Hazard analysis