Alex Rapel

Background

About Alex Rapel

Notified Body Lead Auditor for MDR, IVDR, MDSAP, ISO 13485 and ISO 9001, technical files reviewer (MDR, IVDR) & project manager. Quality Assurance & Regulatory Affairs manager. Experienced in active medical devices and in-vitro diagnostics medical devices. Experienced in design and manufacturing of medical device software, high complexity mechanical, optical and electronic assemblies. Experienced in metal, plastics, textiles and chemical processing. Experienced in multiple international standards and product-specific regulations. Experienced in customer & authorities audits. Core Specialties Current: Notified Body Lead Auditor for MDR, IVDR, MDSAP, ISO 13485 and ISO 9001, technical files reviewer (MDR, IVDR) & project manager. Past: Quality Management and QA, Regulatory Affairs, GMP, HACCP, internal audits, risk analysis, CAPA, FMEA, quality team leader, suppliers evaluation, risk and quality control plans, regulatory affairs, procedures writing, SPC, calibrations, measuring equipment, ERP & PLM systems, configuration control, ECO handling, quality relations with supervising organizations, customers and suppliers, management reviews. Duties Acting as a leader and focal point for all QMS, QA and RA activities. Directing and guiding a team of QA & QC specialists. Monitoring and auditing of products and processes for quality, legislation and regulatory compliance. Coordinating new products submissions (CE, FDA). Coordinating MRB process. Review, update and implementation of quality plans. Ensuring organizational functions awareness of regulatory requirements and customer expectations. Initiating and leading quality and regulatory compliance projects. Coordinating investigations of customer complaints and CAPA process. Preparing and analyzing information for the purpose of Management Review. Coordinating outsourced regulatory activities. Participating in R&D-related projects, incl. FMEA, DRs and V&V activities. Communicating quality and regulatory matters with customers, suppliers and subcontractors. Communicating with supervising organizations: Notified Body, FDA, SII, CSA, UL. Performing suppliers and subcontractors evaluation incl. on-site qualification audits. Planning, carrying out and reporting results of internal audits. Performing regulatory assessment of changes, as a part of ECO handling process.