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Data Entry Document Specialist

Location:
Naples, FL
Posted:
January 26, 2023

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Resume:

Wilmari Esquilin-Santiago

References Available upon Requested

239-***-****

**** ****** **.

Ave Maria FL, 34142

adux5h@r.postjobfree.com

adux5h@r.postjobfree.com

Education:

Polytechnic University of Puerto Rico – Masters- Manufacturing Competitiveness/ Major in Quality Management – 2015-2018

Courses include: Lean Manufacturing, Operational Management, Foundation in Quality Concepts and Assurance, Six Sigma, Audit Program Management, Assessment Tools to Improve Business Performance, among others

University of Puerto Rico at Humacao – Bachelors – Biology/Microbiology- 2005-2007

University of Puerto Rico at Carolina - Pre-Nuclear Medicine Technology Program 2002-2005 Work Experience:

Arthrex Inc., Ave Maria, FL: QA Sterilization Specialist – January 7, 2019 to Present

Responsible for working with Sterilization Processes to prevent quality discrepancies and help determine the root cause and drive corrective action.

Execute such activities concerned with development, application, and maintenance of quality standards for industrial processes, materials, and products.

Optimized data collection procedures and generated reports on a quarterly basis or as requested.

Responsible for analyzing data in order to drive successful business solutions.

Initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields.

Execute developed methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.

Assists in areas of Quality Control, Sterilization processes, Product evaluation such as customer complaints, Research and Development, and Receiving Inspection.

Responsible to create, assigned Action Plans, Evaluated, and dispositioned NCRs related with Sterilization processes.

Arthrex Inc., Ave Maria, FL: Quality Control Inspector – October 20, 2014 to December 20, 2018

Performs and documents dimensional inspections on all parts per Arthrex’s specs with a minimal number of mistakes recorded, following GMP, FDA and ISO guidelines.

Assists in writing work instructions as required, in addition to nonconformance reports following inspection procedures with minimal number of mistakes, preparing graphs or charts of data to be entered in the computers for analysis

Able to interpret engineering drawings, schematic diagrams, and/or formulas, consulting with management or engineering staff to determine quality and reliability standards.

Able to record test data and evaluate their results, applying statistical quality control procedures.

Able to identify and selects products for tests at specific stages of the production process, testing products for range of qualities, such as dimensions, performance, and mechanical, electrical, or chemical characteristics.

Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.

References Available upon Requested

Capable of setting up and performing destructive and nondestructive tests on materials, parts, or products to measure performance, life, or material characteristics.

Helped to decrease Downtime by QC Inspectors in a 25%. Arthrex Inc., Ave Maria, FL: Machining Operator - May 2013 – October 2014

Inspect, assemble, finish, clean and package medical “parts” according to Arthrex work instructions and policies

Support the production of over 15k assemblies weekly in a medical clean room environment.

Promote safe assembly practices which contribute to reducing accidents 43% in a single year.

Pall Life Sciences Fajardo, PR: Quality Documentation Technician June 2010 – June 2012

Data entry tasks in an organized and retrievable manner.

Assisted with manufacturing, inspection and packaging along the production line with the use of specialized equipment.

Pall Life Sciences Fajardo, PR: Machining Operator October 2009 – June 2010 Assembled, inspected and packaged products according to company’s procedures to obtain quality results.

Skills, Knowledge and Abilities:

Excellent utilization of documentation skills regarding manufacturing and quality-related documentation.

Knowledgeable in process improvement protocol.

Experience working with LIMS.

Vast experience with ISO, GMP, FDA, GDP and OSHA regulations

Proficient in QAD, SAP, Power Point, Excel, Word, Publisher software.

Ability to work with manufacturing equipment in a proficient manner in order to acquire data or test results.

Knowledge in statistics, mathematics and analytics.

Experience updating IP-sheets according work order requirements.

Contributed to reduce in a 25% the Downtime by QC during production process.

Experience working on Peel Testing Process at packaging validation area.

Knowledgeable with sterilization process and laboratory equipment.

Ability to write work instructions, summaries and/or reports upon completion.

Proficient in maintaining proper quality standards, ensuring operational effectiveness of equipment and processes.

Knowledgeable in the process of analyzing and solving problems using PDCA, DMAIC methodologies, 5S’s, poka-yoke, Root Cause among others.



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