Carlos Reyes-Portalatin
3628 Park East Dr, Beachwood, OH 44122
(612) 251-8146 (440) 561-7327
Profile
Over 17 years on manufacturing; quality; software testing and/implementation; and design assurance on the Pharmaceutical, medical devices and electromechanical industries can be used for success of my employer. I have experience developing technical documentation, testing procedures, data gathering and analysis.
Skills & Awards
Bilingual Spanish and English.
Lean Manufacturing
Language English-Spanish.
Lean Manufacturing Team Leader.
Kaizen
5s
APQP
Demand Flow Manufacturing
Project Management
ISO 13485 - Quality Management Standard for Medical Devices
GMPs
FDA CFR 21 Sec 800 - QUALITY SYSTEM REGULATION
UL/IEC-60601
EU COUNCIL DIRECTIVE 93/42/EEC
Experience with Risk Assessments
Experience with Design Controls
Experience in testing and inspection equipment.
Project Management
GD&T (Geometric Dimensioning and Tolerancing)
DOE (Design of Experiments)
ASME (American Society of Mechanical Engineer)
C.E.I.I.M (Student Chapter of the Institute of Mechanical Engineers) Directive Member.
Computer Literate: MS Office, MS Access, AutoCad 12, C Language, Basic, Fortran, Pascal, MathCad, Corel Draw, Internet, Mechanical Engineering Applications, Visual Basic 5.0, Ms Project. Unicam 6.0, MRP Software (Mapics, Man-Fact), Circuit Cam. Cam 350, Solid Works.
Computer Hardware and Software Expertise.
Network Hardware Knowledge, (Hubs and Routers)
Network LAN Protocols (TC/IP, IPX/SPX, NetBEUI)
Operative systems Knowledge (WINDOWS 3.1,95, 98 & NT 4.0; DOS 6.22, Mac OS, UNIX)
Network software (Win NT Server, Novell 3.11,Win2000)
Design of Experiments.
EIT (Engineer-In-Training) Certification, PR#19485 (Valid in Most States)
MRP/ERP
Component Recognition Training
Soldering Techniques Theory
Health and Hazard Communication Management Training.
ISO 9002 Internal Auditor.
IPC-610C. Class I, II & III (APEX 610)
Electronics Workmanship Standards.
SPC (Statistical Process Control)
Auditor, Professional Engineers and Land Surveyors Association of Puerto Rico (Florida Chapter, USA).
PPM & DPMO Analysis.
Siemens Siplace Software Platform Knowledge
Experience
SQA, Inc Cleveland, OH Apr/14 to Present
Client Philips Medical
Supplier Quality Engineer (Independent Contractor)
Accomplishments:
- Qualified 200+ Parts for FDA Remediation Project on time.
- Develop and maintained good working relationship with suppliers to assist customer achieve deadlines.
Duties:
Performing Supplier Quality Duties.
Executing Parts Specification Verification Protocols
Assisting suppliers on the Parts Specification Verification Protocol.
Perform and Manage SPQ (Supplier Parts Qualification)/PPAP (Production part approval process) for FDA Remediation Project.
Train Project New Hires
Pharma-Bio Serv, Inc Juncos, PR Sept/13 to Dec/13
Client AMGEN
NC-CAPA – System Owner Engineer (Independent Contractor)
Duties:
No Conformance Investigation Owner and Management
Corrective and Preventive Action (CAPA) Owner and Management
System Owner Environmental Monitoring System (EMS).
System Owner Syringe Filling System.
Administers Preventive Maintenance Program for EMS and syringe Filling System.
Perform Non-Conformance (NC) investigations and generate reports.
Conde Induservices, LLC Guayama, PR May/12 - Sept-13
Client Pfizer Consumer Heathcare
Validation Specialist/Reliability Engineer/Project Manager (Independent Contractor)
Accomplishments:
Assisted on the Implementation of EAMS, a web based Equipment Asset Management Data Base System. This system is replacing SAP and CalMan
Duties:
Create and validated BOM for Manufacturing Equipment Instruments.
Create Preventive Maintenance Program for New Equipment for PNS/FAI Project.
Perform FMEA to determine Reliability Ranking for Maintenance Program.
Execute Validation and Verification Protocols for Continuous Coating System.
Execute Site Acceptance Tests for Solution Preparation Systems.
MC Assembly Boston Winchester, MA April/11 – Dec/11
Process Engineer
Accomplishments:
As Lean Manufacturing team leader at the SMT lines, advised and trained employees by use of lean and kaizen.
Developed and Implemented SPC Metrics on this Facility.
Implemented and introduced the Automated Stencil Cleaner.
Duties:
Responsible for new products introductions, process and instructions. SMT area supervisor and process improvement team member.
Manufacturing new equipment installation coordinator, Develop a SMT Process production improvement plan.
Write Manufacturing Instructions for the company products. Assisted the company in identifying and resolving problems.
Design the lay-out and set-up processes on the test, integration pack and shipping areas.
SMT personnel supervisor.
ISO 9002 Internal Auditor and SPC exposure.
Knowledge on Assembleon AX,M Series GEM Series Pick and Place: DEK and MPM Screen Printers; and Elecrovert And Vitronics Soltec Reflow ovens.
Prepare PCB and Assembly Quotes.
Perform PCB DFM Analysis.
Design and expedite SMT Stencils.
Generates oven and wave solder operation recipes.
Oversees the Calibration system
Create, maintain, and repair test fixtures/testing equipment.
Analyze the quality data to seek and prepare continuous improvements projects in the manufacturing areas.
Medtronic (Neuromodulation) Minneapolis, MN May/07 – Feb/09
Design Assurance Reliability Engineer/Program Manager
Accomplishments:
Assisted on the implementation on the Risk Management System, that was critical for the Neuromodulation Division to address and correct issue highlighted in a warning letter.
Duties:
As Design Assurance Reliability Engineer work in collaboration with Design, Manufacturing, Regulatory Affairs, and other Quality partners, perform or contribute to analyses and testing to understand product and process robustness, drive hardware quality and reliability improvements, and verify compliance with design, manufacturing, Quality System and regulatory requirements.
Provide design input by reviewing and assessing legacy product performance and new technology risks.
Contribute to the establishment of project quality and reliability goals and metrics to drive continuous improvement.
Establish or review specifications/requirements for components, subassemblies, products and processes to assure adequacy and testability of requirements relative to use conditions. Lead or participate on cross-functional teams in...
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