Nadia Aboutalebi

Design Quality Engineer @Kls Martin North America

Jacksonville, FL, US

Lead Design Quality activities for new product development across Class I, Class II, and Class medical devices (e.g, IPS Forearm, IPS Distraction, Thoracic Screw guides, Adjustable cranial plate, Pectus Bar, IPS Hand, Forearm joint replacement, Trays, IPS Models, IPS Splints, IPS Thoracic and, Class I Instruments).• Reviewed and authored 120+ DHF and technical documents, design verification and validation protocols and reports, biocompatibility assessments, and usability evaluations to support FDA 510(k) and Health Canada submissions.• Ensured complete, traceable, and audit-ready Design History Files (DHFs).• Investigated complaints related to design and verification gaps.• Owned the Engineering Change Notice (ECN) workflow, 200+ changes were completed to drive continuous improvement.• Supported DHF audits with zero major nonconformities across 3 FDA/MDSAP inspections.• Collaborated and led cross-functional teams including R&D, Regulatory Affairs, Manufacturing, and Post-Market Surveillance teams.• Collaborated on updating pFMEA, risk mitigation strategies, verification and validation (V&V) activities, • Streamlined the Engineering Change Notice (ECN) process and work instructions.• Collaborated on the implementation of digital ECN workflow to enhance stakeholder responsiveness, traceability.