sal4time

I am a qualified Lead Auditor for ISO 9001 and have background in both Medical Devices and Telecom industry. I'm an expert in Quality Management Systems (QMS) including conducting gap analysis and merging Quality Systems into one. My expertise include: - Quality Systems audits in compliance to ISO 9001, ISO 13485, ISO 14971 and FDA Requirements for medical products. - Training employees to become qualified Internal auditors - Generating yearly audit schedule(s), creating/updating SOPs/forms/templates. - Writing various types of technical reports i.e. Design/Development plans, Risk management plans, Protocols, Customer Complaint letters. When writing, I always keep in mind the needs of the end users, conducted research on respective topics through personal observations, Internet-based research including having conversations with subject matter experts (SMEs) and other technical specialists. - Great in root cause analysis, corrective and preventive actions, design files, etc.