Plant Manager Medical

Israel Portes

A # **, Ensanche La Hoz

La Romana, Republica Dominicana

Nationality: Dominican

ID #: 023-0045728-6

Married

USA Valid Visa

Qualifications in brief

Continuous interaction with customer to guarantee Quality expectation is met.

High experienced on operations management for more than 20 years.

Capable to function academic and professionally in English and Spanish.

Ability to work effectively under stressful environment.

Adapt to new situations and comprehend instructions quickly and thoroughly.

Initiative-taking and unafraid of hard work.

Well experienced on manufacturing of disposable medical devices.

Knowledge of FDA guidelines, ISO 9000, ISO 13485, OSHA 18001, Lean Manufacturing, Six Sigma Methodology and Familiar with ISO14000.

QS Auditor for more than 15 years.

Enjoy new Challenges and always willing to learn new products.

Active in promoting industry techniques and personal education development skills.

Education

MBA in Quality and Social Corporate Responsibility

EUDE, European Business School – October 2020

BBA in International Business

Innova College, 2014

AAS in Industrial Technology with Quality Control Emphasis

Broome Community College, Binghamton, NY, USA, 1997.

Diploma on Project Management and Analysis

Intec / USAID / Georgetown University, 1999

Diploma on Operations Management

Universidad Dominico-Americana. 2004

National Instructor for Technical and Professionals Skills

Infotep. 2005

Six Sigma Green Belt

Quality, 2006

Work Experience

DAS Medical International

Operations Plant Manager November 2012 to date.

Plan, Organize, direct and run optimum day-to-day operations

Responsible for the management of Supply Chain, Manufacturing, HR, Accounting, Maintenance and Administration departments.

Responsible for the reward and incentive program for all personnel.

Management Approval Responsibility to acquire personnel, raw materials, machinery and other needed resource for the operation).

Direct contact with Company Owners on the day to day company operations.

Management Responsibility for requesting and managing all governmental legal permits required to operate our company within the free trade industry.

Represent the company at the community and professional events.

Project Leader for the Global Cost saving team.

Monthly Meeting with all personnel to communicate company business results and future plan.

Lead of the Weekly Operational meeting with Management staff and Corporate.

Over 500 employees and growing.

Production and Quality Management System Consultant. March 2012 - Nov. 2012

Creation and implementation of the Operational and Quality Systems (QSM, Mfg. Procedures and all other applicable regulations).

Company was certified at first audit surveillance by a German Notify Body with no observations.

Remington Medical, S.A

Plant Manager Feb. 2011 - March 2012.

Founder and first employee for the installation of Remington Medical S.A.

Project Leader to the transfer of Remington Medical Inc. located in Alpharetta, Georgia, USA to Las Americas Free Zone in the Dom. Rep.

In charge to procure resources (personnel, local raw materials, tools and others).

Plan, Organize, direct and run optimum day-to-day operations

In charge for requesting and handling all the governmental legal permits in order to be able to operate our company within the free trade.

Tabacalera de Garcia S.A.S (IMPERIAL TOBACCO)

Human Resource Special Consultant, March 2010 up to Jan, 2011.

Developed and Implemented site strategic Disaster Recovery and Business Continuity emergency plans for: country evacuation, hurricane, explosion, earthquake, kidnapping, loss of facility, IT contingency, dawn raid and any other main disaster event possible.

Microtek Dominicana, S.A. (Ecolab)

Production Plant Manager, March 2001 to Jan 2010

Accountable for a Budget over 1.2 million dollars annually.

Responsible to coordinate planning and production schedule with production general supervisors.

In charge of the production management which represented 95% of the global production for the company as a whole.

In charge for the reward and incentive program for all personnel.

In authority to request any resource needed for production operation (personnel, machinery, materials, space, tools, equipment, and others.

Project Leader Manager to transfer several production lines from:

-New Mexico, Albuquerque, - Columbus, Mississippi,

-Netherlands - Jacksonville, Florida.

-Athens, Texas - Salt Lake City, Utah

Entrepreneur of the Lean Manufacturing philosophy and Six Sigma methodology.

QA / RA Manager & Management Rep. Dec 1999 to Mar 2001

Deka Medical, Inc. (Bought by Microtek in 2001)

Responsible for compliance of ISO Quality systems, GMP’s, EN guidelines and FDA QSR regulations for medical devices manufacturing control.

Accountable for the following departments: Incoming inspection, in-process quality control and QC lab inspection, Document control center, complaint handling and failure investigation, GMP Auditing and Supplier evaluation, CAPA management, process validation and equipment calibration.

In Charge of the assurance that all products are manufactured within the specification customer requirement and the use of procedures and specifications for all products and process are in place.

Achievements

o Improvement the product output quality substantially by 45%. o Implemented a new in-process inspection method.

oEstablishment of final QA release for finished products to be shipped.

oEstablishment of Quality plan for product transfers.

oThere was the need to merge both Quality Systems. The Deka Medical Qa system was the one chosen as best to be implemented due to the robust platform and accomplishment in results.

Medical Product Proficiency

Ultrasonic, Ultrasound and Microscope cameras drapes.

Pouches (Collection, Urology, and Fluid). -Clean Operations Kits.

Surgical boots, gloves, Hoods & Gowns. Non-Woven Drapes, Surgical Suture and Needle, Wound Evacuator Pump System,

Gut, Silk and Nylon sutures, Surgery Needles, Biopsy Needle,

I. V. Sets, Blood Pressure Cuffs, Cardiopulmonary Resuscitation devices.

Shoe and Head Covers. -Banded Bags for general purpose.

Equipment Accessory Drapes (Costume Made)

Manufacturing Method and Process Background

Bar Sealer

Die Heat Seal

Radio Frequency Seal

Ultrasound Seal

Ultrasonic Seal

Cutting and Seal Machines

Manual Process

Gluing Process

UV Printing Process

UV Drier Process

Injection Molding

Silk Screen Printing Frame

Trimming and cutting Machine for poly and Fabric Material

Labeling and packaging control

Recognitions and Memberships

Conference Guest Speaker: Topic: Quality System in a Globalize World.

Innovative Practices in Quality Broome Community College and ASQ in Binghamton, NY June 6, 2008

Conference Guest Speaker: Topic: Leadership

Excellence in Leadership through Continuing Education and Training

USAID / Georgetown University / PUCAMAIMA / CASS / ASQ / ADECASS y BCC 10 y 11 de November del 2000

Certificate of Achievement as Chairman

ASQC Student Chapter, Broome Community College June 4, 1997

International Association of Lion Clubs

Club de León Romana Centro. Since December 2006

American Society for Quality Control

Binghamton Section, Since September 25, 1996

International Scholastic Order – PHI THETA KAPPA Society

Mu Eta Chapter, Since April 28, 1996

USAID Alumni Association

Since 1997 Personal Reference are available Upon Request.

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