Daniel Colón Email & Phone Number

Engineering professional with over 9 years of experience in the MedTech industry including field/customer service, manufacturing, Regulatory Affairs and Quality Assurance, and post-market surveillance (PMS).Currently a Principal Consultant at RQM+.- Sound understanding of ISO 13485, ISO 14971, 21 CFR Part 820 and 830, EU MDR 2017/745 and EU IVDR 2017/746.- Extensive experience with PLM systems (Agile, FOCuS, eCentral), QMS/document change control systems (CATSWeb, SmartSolve, TrackWise), ERP systems (MFG/PRO, QAD), and Learning Management Systems (ComplianceWire).- Working knowledge of Lean Six Sigma tools and techniques.- Experienced in PMS, Corrective and Preventive Actions (CAPA), master data management, Unique Device Identification (UDI), Health Hazard Assessments (HHA), process engineering and improvement, process verification and validation, and manufacturing quality.

Listed skills include Matlab, Microsoft Office, Teamwork, Data Analysis, and 13 others.

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  Principal Consultant, Technical Lead

  Rqm+

  Oct 2022 - Present - Seattle, Washington, United States

  • Serve as Technical Lead and Internal Reviewer for a large-scale PMS focused project. Provide and develop tools and processes for creating components of PMS requirements for medical devices and diagnostics in the EU under EU MDR 2017/745 and EU IVDR 2017/746.- Review deliverables, ensuring they meet the highest quality standards, client requirements, and deadlines, including PMS Plans, periodic safety update reports (PSURs), PMS reports, PMCF Plans, post-market performance follow-up (PMPF) plans, PMPF reports, and Health Canada Summary Reports (HCSRs).- Mentor, influence, and provide guidance to PMS resources and client as needed.• Draft and deliver PMS Plans, PSURs or PMS Reports, and HCSRs as appropriate, to fulfill applicable requirements of EU MDR or EU IVDR. This work includes the following data analysis elements: complaint data analysis, public adverse event and recall database searches, CAPA/SCAR assessment, trend analysis, usage data (unit sales or install base), and risk mapping.• Present to, facilitate reviews, and consult with client cross functional teams including but not limited to RA, QA, Marketing, PMS, and R&D.