Steve ('Stephen') Roy Email Address

Vice President Quality Assurance North America and Director NPD and Director Manufacturing and Test Engineering

Invacare Corporation (NYSE: IVC), headquartered in Elyria, Ohio,

Turned around organization under a Consent Decree, cleared all 483's/Warning letters globally with ZERO 483's in less than two years. Senior-level Quality, Regulatory Affairs, New Product Introduction, Engineering, Operations, Manufacturing Engineering Executive with extensive Medical Device/Tissue/Biologics Industry experience in leading corporations such as GE Healthcare, Philips Healthcare, Cook Medical, Invacare, RTI Surgical and extensive experience in Quality, Regulatory Compliance, Design, Complaint handling, Operations, Reliability Engineering, and Supplier Quality. Deep and broad knowledge in Consent Decree, 483, Warning Letter Remediation, Quality, Regulatory Compliance, Quality Management Systems (QMS), Test Eng, Mfg. Eng, Reliability, NPD, Operations, Supplier Quality, DFSS, Design for Excellence (DFx), Lean, Six Sigma, Project and Program Management in the Medical Device Industry. Transformational Leader, Change Analyst, Results-Oriented, Strategic, High Energy, Innovative, Accountable with High Standards of Integrity. Received GE Management Award for Leadership. SPECIALTIES: •Consent Decree Remediation, 483/Warning Letter Remediation, Voluntary shutdown Remediation •Quality and Compliance Remediation, DHF Remediation, Turned around Organizations •Quality Management System (QMS), Strategic Planning, Change Management, Execution •Operational Excellence, Good Manufacturing Practices (GMP) •Value Stream Mapping, TOYOTA Mfg. •Lean, 5S, Six Sigma, Design for Six Sigma (DFSS), Statistical Process Controls (SPC) •Quality, Cost, Delivery, Performance Improvement •Supply Chain Strategies, Supplier Quality, Purchasing Controls •NPD, 510(k) submission, Design for Excellence, Value Engineering •Sustaining Engineering, Refurbishment, Re-manufacturing, Service •CAPA, Pre/Post Market Surveillance, Failure Mode Effects Analysis, Cyber Security, Informatics •Verification and Validation, Production and Process Controls (IQ, OQ, PQ), Purchasing Controls •Computer System Validation, Design Controls, Global Design Transfer •IEC 60601, ISO 13485/14969/14971, 21 CFR 820/803/806, MDSAP, RESNA, EU MDR, 21 CFR 1270/1271