Monica Lozano

About Monica Lozano

Senior Quality and Compliance professional well versed in; Medical Device Quality Systems…

Experience

1. Sr Compliance Consultant

   Maetrics

   Mar 2017 — Present · Various Locations, US

   Team Lead and primary point of contact for the client, outside units, clinicians, complaint specialists for the Device Complaint Handling Unit for Medical Devices and Combination products, and SME for the complaint handling process for one of two systems, managing a team of 30 individuals.Daily presentation of performance reporting data and metrics to senior management.Coordinate with team to mitigate team challenges, drive productivity, provide clear guidance and support, and manage team resources.Partner with cross-functional teams to coordinate and identified continuous quality and process improvement opportunities.Developed operational processes and mapped, as appropriate, depicting procedure relationships.Created procedures, work instructions, and supportive documentation.Gap analysis of QMS PMS for EU MDR compliance and updates.Conducted gap analysis on SOPs on non-conformances, risk management, design and development and reportable design changes.Managed CAPAs supporting compliance gaps found within the client’s Quality Management System related to ISO 13485:2016 and MDSAP. Work emphasis on ISO requirement knowledge on: labeling, complaint management, adverse event reporting, post marketing surveillance, recall and advisory notices.Conducted remediation activities on legacy NCRs to determine if non-conformances were dispositioned correctly and within compliance of CFR 21•••90.Determined whether the original corrective actions addressed the non-conformance adequately to mitigate the risk for the possibility of negative effects to the product and/or the patient.Sought knowledge and/or understanding of products and manufacturing processes by meeting with divisional and manufacturing engineers for proper assessments. Evaluated any gaps in the NCR’s documentations, investigations, Device History Records, processes and materials to assess if a Health Hazardous Evaluation was required.

Education

• University of Hartford

  Bachelor of Science (BS)

Skills

• Microsoft Word
• 21 Cfr Part 11
• Iso 13485
• Post Market Surveillance
• Agile Project Management
• Regulatory Affairs
• Microsoft Office
• Quality Assurance
• Design Control
• Summit
• Analysis
• Process Improvement
• Complaint Investigations
• Knowledge Base
• Quality System
• V&V
• Troubleshooting
• Organization
• Regulatory Compliance
• Vba
• Adverse Event Reporting
• Sql
• Visio
• Powerpoint
• Microsoft Excel
• Access
• Cgmp Practices
• Business Process Improvement
• Fda
• Sap
• Odbc
• Surgical Instruments
• Project Management
• Medical Devices
• Adobe Professional
• Business Analysis
• Capa
• Software Documentation
• Sdlc
• Adobe Acrobat