Carlos Manuel Ruvalcaba Arredondo
Cd. Juarez, Chihuahua
Summary
15+ years of medical device experience with Johnson and Johnson. Motivated Professional Senior Manufacturing Engineer with experience in Suppliers, Equipment and Process Validations including IQ, OQ, PQ, Computer System Validation (CSV). Supplier Qualification, Packaging, Labeling and Manufacturing Process capable of making significant contributions with my knowledge and skills toward accomplishing company goals.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Equipment Software Validation Engineer
- Implementation of new software revision for Instron Pull Tester machines for all manufacturing areas at Cordis de Mexico
- IQ/OQ Protocols
- QA Software Installation Protocol
- System Validation Protocol
- System Baseline Description
- System Requirement Specification
- Data Migration Protocol, Completion of documentation required for SDLC Methodology in order to validate New Clean Room at Cordis de Mexico new facility.
Process Validation Consultant Engineer
Ethicon Inc
05.2008 - Current
- Process Validation Engineer in the Burdock, BCP1, iFAS (automated equipment) project transfer (Europe to Juarez Facilities) and Suture Complexity developing the following activities:
- Manufacturing Process Validation for Products transferred from Europe to Juarez Facilities
- Functionality test of Process Validation (PJM, Product SR) to analyze its behavior and efficiency based on Engineering Studies (OQ, PQ and variance studies like Cp, CpK, DOE, Pp, PpK, CpM) using Minitab
- Modification of Specifications for processes of products transferred to Juarez Facilities
- Supported Engineering and New Products.
Packaging/Process/Validation Consultant Engineer
BEPC providing services, Cordis de México
06.2008 - 05.2011
- Involved in the CNV project transfer developing the following activities:
- Align the related CNV micro-catheter manufacturing processes to the current practices
- Align CNV Microcatheter routers according to actual flow in line
- Equipment Validation
- Involved in the MP and GLS project with Labeling and developed the following activities:
- Change label specifications, Branch Item Master, Item Master info, ERPs and Inspection Reports to call out Trans Therm 2 label material
- Activated GBS into JD Edwards to show GBS as an alternative supplier for labels
- Update packaging components as required, in order to add or remove applicable languages from the IFU and/or Labels in all marketed Cordis Product
- Involved in the Codman project with Labeling for development of the following activities:
- Update CNV Labeling to reflect Codman as the legal manufacturer
- SQS
- MWIs, QWI and QS
- Routers, BOMs, ERPs, BIMs, BOM Specification,
- Labels, Specifications, Inspection Reports, IMIs and BIMs
- Components Qualification and Scrap Factor for new components
- Update packaging components as required, in order to add or remove applicable languages from the IFU and/or Labels in all previously CNV owned products
- Obsolete sampling plans such as military standard and replace with current plans
- Complete Supplier Qualification for Corrugated Boxes developed following activities:
- Creation and Closure of CRSF (Change Request Strategy Form)
- Create cPDM and JDE structure (Part numbers, IMIs, BIMs, ERP, Inspection Reports and Specifications)
- Create Supplier Qualification Strategy
- Create Engineering Study Protocol to validate supplier’s new part numbers
- Create Engineering Study Protocol Report to prove supplier’s new part numbers validation
- Support supplier PPQ and First Lot Inspection
- Coordinate sterilization tests for corrugated boxes samples
- Equipment and Software Validation activities for the second manufacturing line of the Nevo Catheter family of products and developed the following activities:
- IQ/OQ Protocols
- QA Software Installation Protocol
- System Validation Protocol
- System Baseline Description
- System Requirement Specification
- System Application Form
Packaging / Process Validation Consultant Engineer. •Packaging Validation Engineer
BEPC, Cordis de México/Ethicon Inc
05.2008 - 05.2009
- Implementation of New product Labels (Inner & Outer) at Codman area that involves the Supplier Qualification for GBS developed following activities:
- Creation and Closure of CRSF/CP (Change Request Strategy Form-Change Project)
- Update Adaptiv and JDE structure (Part numbers, IMIs, BIMs, Inspection Reports and Specifications)
- Update Supplier Qualification Strategy
- Create Engineering Study Protocol to validate supplier’s new part numbers
- Create Engineering Study Protocol Report to prove supplier’s new part numbers validation
- Support supplier PPQ and First Lot Inspection
- Coordinate sterilization tests for Inner and Outer sample labels.
Engineering Assistant
Ethicon Inc
02.2007 - 05.2008
- Documented and closed NCR client complaints
- Documentation of instruments used in manufacture, maintenance, inspection, calibration and validation of the product or the equipment that it requires to assure its efficiency per Ethicon quality systems
- Functionality test of sample material (PJM, Product SR) to analyze its behavior and efficiency based on Engineering Studies (PQ, PPQ and variance studies like Cp, CpK, DOE, Pp, PpK, CpM) using MINITAB
- Complete validation of equipment used on the production line
- Define and test Post IQ Functionality to verify that the equipment fulfills the requirements and efficiency in it is designed to
- Modification of Specifications for processes when changes are required
- Leader for the IE activities from Micro-catheter product transfer (MOST, Layout, design fixtures, flow material, work instructions, process specifications, etc)
- Defined Preventive Maintenance for equipment installed on production line
- Supported Engineering and New Products and Core Services.
Engineer Assistant
Cordis de México
05.2006 - 11.2006
- Involved in the project to change out an obsolete labeling system (Wintrack) with implementation of a new labeling system using Network servers located in Miami Lakes (WWPI)
- Computer and Printer Equipment validations as well as changes to this equipment for all types of catheters used in DX
- Document creation used in evaluations and validations of new alternatives for materials for new and existing product packing
- Creation and translation of protocols
- Proposed improvements in the packing processes using lean manufacturing, increasing production, improving quality control of products, and saving operational costs
- Created Protocols for Label Printers for new system (WWPI)
- Equipment validations assuring printer quality and accuracy of operation
- Purchase Requisitions
- Supported packaging Tech Ops core services.
Engineer Assistant
Delphi Mexico Technical Center
05.2005 - 05.2006
- Supported Packaging Engineering department
- Developed lab validation activities to evaluate the reliability of the packaging configuration for various automotive products
- Tested various packaging boxes for a Ford motor A/C component in order to minimize shipping and packaging costs
- Defined and created flows & charts for packaging process time analysis
- Developed a software tool and manuals “Pack Project Tracker” using Visual Basic.Net software to store, control, and retrieving information for packaging projects
- Developed a software tool and manuals “RFQ Tool” using Visual Basic.Net software to create Purchase Orders using a standard format
- Created a base structure for the Web site “Packaging Share Point” to centralize packaging information
- Supported Packaging Engineers by creating and filling out packaging FMEA formats.
Education
Degree (BA) -
Instituto Tecnologico Y De Estudios Superiores De Monterrey (ITESM
2008
Skills
- Microsoft Office (Word, Excel, Power Point) *High School Technician certificate
- Internet, Minitab, Matlab, AutoCAD
- Visual Basic - certified
- Visual FoxPro - certified
- Adobe Acrobat Professional
- Leadership, Planning, Organized, Communication Skills
- Team Player, Problem Solver, Adaptable, Responsible, Motivated
Certification
(2007)
Green Belt Six Sigma Certification by Arizona State University
Languages
English
Advanced (C1)
Timeline
Packaging/Process/Validation Consultant Engineer
BEPC providing services, Cordis de México
06.2008 - 05.2011
Process Validation Consultant Engineer
Ethicon Inc
05.2008 - Current
Packaging / Process Validation Consultant Engineer. •Packaging Validation Engineer
BEPC, Cordis de México/Ethicon Inc
05.2008 - 05.2009
Engineering Assistant
Ethicon Inc
02.2007 - 05.2008
Engineer Assistant
Cordis de México
05.2006 - 11.2006
Engineer Assistant
Delphi Mexico Technical Center
05.2005 - 05.2006
Equipment Software Validation Engineer
Degree (BA) -
Instituto Tecnologico Y De Estudios Superiores De Monterrey (ITESM
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