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Maritza Zayas
Sr. Quality Consultant
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Visionary, passionate, customer focus, lean thinker, results driven and multi-functional senior manager experience.  Experience in regulated and high structured manufacturing environments; which cover FDA, FAA, ISO and Aerospace standards. Track record of consistent contributions to increased production, quality, profitability and customer satisfaction and cost reduction effectiveness. Persuasive leader, team builder and negotiator. Key contributor to strategic business planning process. 

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Experience

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  • Production & Process Control and Labeling Operation’s External Workstream Lead supporting Quality System Remediation efforts - CAPA Coach and P&PC SME - Cook Medical, Inc via C2C Enhance Compliance Inc.  

  • Perform independent reviews for CAPAs at different phases. Provide guidance to CAPA Owner and Coordinator - CAPA Independent Reviewer via C2C Quality Consulting Group.

  • Supported customer as Third Party Reviewer of Nonconformance Investigations backlog and provided training - NCR SME - Zimmer Puerto Rico.

  • Supported the design, training and implementation of a Risk Based Nonconformance New Process, introducing levels of investigation based on patient severity score - Quality Consultant via C2C Quality Hub Inc.

  • Lead Auditor responsible of preparing annual audit schedule, perform audits and preparing final audit reports and coach auditors. Support Remediation efforts by writing and executing NCR remediation protocol. Performed CAPA Audit; CAPA System versus QSR and Internal procedures - Zimmer Puerto Rico - Sr. Compliance and Quality Consultant via C2C Quality Consulting Group.

  • Responsible for conducting audits and deliverable verifications related to Global Remediation Quality Plan with focus on Regulations, Standards and Process Compliance - Depuy Synthes - Sr. Compliance and Quality Consultant via C2C Maetrics.  

  • Responsible for the CAPA Program, providing guidance to CAPA owners, and monitoring CAPA Program monthly performance - Mylan LLC - Quality Consultant via C2C Business Excellence Consultant.

  • Key staff member of the Covidien Quality Assurance and Compliance Organization, leading the Supplier Quality Management organization - Quality Supplier Manager - Covidien Puerto Rico.

  •  Supported several manufacturing lines through collaboration by learning the processes, providing direction, consulting and approving final reports of nonconformance product, MRB Board, Audits and Process Validation - Quality Section Manager - Covidien Puerto Rico.

  • Managed twelve product lines, manufacturing and packaging, with one manufacturing supervisor and four shift leaders in a 24/7 operation. Responsible to manufacture 150 Million units to support Supply Chain demands in the US and Europe, accomplished zero backorders - Production Manager - Becton Dickinson Puerto Rico.      

  • Translated the “Voice of the Customer” into deliverables. Ensured achievement of company objectives by delegating authority to key supervisors in manufacturing and production control areas. Managed five, built to print, manufacturing lines which included: Cables, Harness, Cabinets/Chassis, Printed Wired Boards, Manual Surface Mount, which supported four site sponsoring divisions in delivering Integrated System - Quality Assurance Manager -  Northrop Grumman Corporation Puerto Rico.    

  •  Managed projects for process improvements, introduction of new technology, and company’s infrastructure of $2M dollars, positioning the company towards a stronger competitive position -  Quality Assurance Manager -  Northrop Grumman Corporation Puerto Rico.        

 

Education

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  • Bachelor of Science in Electrical Engineering - University of Puerto Rico, Mayaquez

  • Master of Business in Technology Management - University of Phoenix, Puerto Rico

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Continuing Education

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  • Certified Medical Device Quality Systems Expert

  • AQS-RABQSA Certified Lead Auditor ISO13485

  • ASQ Certified Biomedical Auditor

  • Certified CAPA Expert

  • Lean Six Sigma Black Belt

  • Mentor, Team Building & Leadership

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