Ana Puente

Design Assurance Lead @Fresenius Medical Care

Lawrence, MA, US

Involved with technical file preparation for FDA Class IIa fluids submission and Health Canada drug products• Continuously review implementation of manufacturing test fixtures for water treatment facility and ensure aseptic practices are being met• Identified, investigated, and carried out corrective actions for CAPAs• Ensure product design documentation and verification is following company’s QS • Involved in complaint meetings and provide guidance on investigation testing • Involved in the regulatory strategy for MDR compliant products to sell in the EU• Assess test procedures and test methods to determine which statistical techniques are appropriate• Evaluate design verification, design validation, and process validation test protocols and reports to ensure compliance with regulatory requirements and quality objectives per FDA guidelines• Manage team to ensure department goals are met on a timely manner• Perform risk gap assessments to ensure risk documentation meets the latest ISO14971 standards and current SOPs/WIs• Audited fluids documentation before FDA and EU MDR submission: design inputs, risk management plan/report, usability engineering reports, labeling changes, design verification reports, dFMEA, biocompatibility reports• Involved in project planning, design verification and validation planning for all applicable projects

University of Massachusetts Lowell

Master of Science - MS, Polymer/Plastics Engineering

Massachusetts Institute of Technology

Certificate, Architecture and Systems Engineering Certificate

Florida International University

Engineer's Degree, Mechanical Engineering