Skill Summary

( Project and Operations Management in Governmental Communications (

Office Administration and Client Relations ( Document Control Systems

Specialist and Office Management ( Contract/ Vendor Management ( Internal

and External Audits Participation. FDA Regulated Industries experience( 9

years in medical devices Industry)

Detailed-oriented professional with extensive experience in administrative

and supplier quality coordination and project management within private

and public sectors including FDA regulated industries. Exemplary customer

support skills, along with commitment to excellence by ensuring that

projects are delivered within scope, budget, and schedule. Develop Public

Relation and Marketing Strategies for Governmental Agencies. Business

consultant responsible for developing strategic operational process and

organizational process.

Experience in project and operations management, documentation management,

and resolution of complex issues, demonstrate professionalism, attention

to detail and collaborative nature. Web page maintenance.

Effective team leader, able to train and mentor professionals in tools,

processes, and procedures.

Skillful at fostering relationships with diverse range of customers,

coworkers, and management

Exceptional communication and organizational skills with ability to work

both independently and as a team member.

Fast learner, adept at quickly learning new procedures and implementing

best practices

Proficiency in Microsoft Office Applications

Fully Bilingual: Spanish and English

Professional Experience

Guaynabo, PR - 2010 to 2013

Sr. Project Manager- Independent Consultant

Project Manager and Business Analyst for different initiatives in the

public and private sectors.

Development, marketing, online and print newsletter, website maintenance.

Quickly gain knowledge of federal and state regulations and applying them

to business requirements for the projects.

Creation of monthly invoices for clients and monthly sales forecasting

reports.

In charge of assisting the hiring process.

Supervised working group consisting of project managers and programmers.

Create, review and approve deliverables according the project timelines.

Acted as Lead Functional / Technical Consultant and managed client

relationships and projects.

Prepare project documentation including proposals, status reports,

deliverables, and manual translations.

Liaison between project team members and executive management, and federal

government.

Responsible for quality assurance of deliverables.

Develop Public Relation and Marketing Strategies for Governmental

Agencies.

Zimmer Manufacturing, B.V., Ponce, PR - 2001 to 2009

Document Control Coordinator / Supplier Quality

Maintained the Suppliers Program including but not limited to: selection,

qualification and approval of suppliers, issue and maintain the Supplier

Approval List and Supplier Audit Schedule.

Issuance, Analysis and follow up of Supplier Corrective Actions.

For 8 years coordinated all aspects of the development, control, review,

revision, distribution and publishing to the Zimmer intranet of Zimmer

Procedures. Principally responsible for the Zimmer Document Control System

and compliance to all applicable procedures, ISO 13485 standard and the

Quality Systems Regulations. Proofreader of all official ZMBV Procedures.

Implemented in Ponce site the Change Management System (electronic

approval system for all documentation).

Implemented CAPA System and procedures

Participation in FDA Audits locally and overseas as "Front Room"

representative.

Active participation in the improvement projects for Six Sigma Green Belt

and Lean Manufacturing.

Ponce Paramedical College (POPAC), Ponce, PR- 1997 to 2000

President's Special Project Coordinator

Coordinate all aspects of development for new enterprises within POPAC

facilities including projects: University Plaza Building at Villa Flores,

New Horizons Learning Center at Rovira Office Park and Emprecorp, SE.

Coordinated Staff and Management Special Activities.

Assisted the General Services Department in the purchasing, inventory and

material disposition process. Trained new personnel on store tasks.

Managed forecasts and budgets as requested by Management.

Participated in Management Staff Meetings

Educational Background

Master Degree in Business Administration - Public Administration - 2010

University of Phoenix, PR

Bachelor Degree in Science -Major: Liberal Arts with minor Office

Administration

Pontifical Catholic University, PR

Extensive trainings and continued education in Lean Manufacturing,

Regulatory Affairs, Good Manufacturing and Documentation Practices, Health

& Safety Regulations, Process Validation, Quality Metrics. Train the

Trainer include:

Certificate on Best Practices for Managing CAPA System - Awarded by FDA

News

Certificate on Conflict Management and Confrontation - Awarded by Fred

Pryor Seminars

Internal Quality Audits Courses & Problem Solving and Root Cause Analysis

Course

Six Sigma Yellow Belt & DMAIC Course

Certificate on Quality System Regulations

Training on How to Handle and behave during FDA Inspections

"C mo Incursionar en Mercados Internacionales" - Sponsored by SBA

Computer Literacy

MS Office: Word, Excel, Power Point, Project, Publisher, Access, Visio,

Social Media Expert

References

Available upon request.

Contact this candidate