XOCHITL RUIZ

QUALIFICATIONS SUMMARY:

Technically proficient and detail-oriented Engineering Validation/Process Engineer with progressive expertise in manufacturing, project/plant management, training, cost estimation, cost reductions/improvements, design reviews, protocol development, validation installations/operations/processes, quality assurance, testing, and strategic planning. Taught and led lean manufacturing teams, trained and facilitated Kaizen events, developed manufacturing cells, implemented 8Ds programs, KanBan, and material flow improvements. Over seven years’ experience in the medical device industry and am very familiar with FDA, Quality System Regulations, and ISO requirements

SKILLS:

Background in Medical devices, electronic boards, battery cables and appliances; Industry process improvement; Design implementation; Auto cad; Lean manufacturing; Value Stream Map; PPAP/APQP and process documentation; MS project

Microsoft Office; Ergonomics; FMEAS; Control plans; Validations; Internal Auditor; Self-motivated individual; Fluent in English and Spanish

EDUCATION:

Universidad Autónoma de Chihuahua Juarez, Chihuahua 2007

Master Degree in Business Development

Industrial Engineer Instituto Tecnologico --- Juarez, Chihuahua 1997 Bachelor Degree as Industrial Engineer major in production

PROFESSIONAL EXPERIENCE:

J & J Ethicon---Ciudad Juarez Chihuahua Jan 2016 to Present

Engineer

• Providing technical support to electrical and mechanical drawings in FAS LEAN-SOT machines, updating around 400 drawings and E-Boms

• Update the process specs and technical justification memos for BSI projects.

• Elaborate documents assessment memos for INK change project.

• Create change orders in order to update technical documentation (MS and PS).

• Update, create and obsolete PFMEAs documents.

Elaborate validation documentation like IQ/OQ and PQ for vantage project consolidation around 800 new codes.

J & J Ethicon---San Angelo TX Dec 2014 to Jan 2016

Process Excellence Engineer

Led, coordinated and facilitated the implementation of Lean Manufacturing efforts, over saw all aspects of the Lean manufacturing initiatives including production line re-engineering, set-up reduction, workplace organization, standardized work, process/work flow improvements and visual management

Trained and familiarized operators, group leaders and support team in “A3” and “DMAIC” for the implementation of “Problem Solving in Manufacturing Areas” to ensure continuous learning and developed the scientific thinking to identify and solve manufacturing

Led cross functional team implementing innovative strategies and dedicated to the principle of continuous improvement to save in cost reduction projects.

Maximatec---Juarez, Chihuahua Feb 2014 to Nov 2014

Manufacturing Engineer

Responsible for completing projects with suppliers to provide an uninterrupted flow of components for assembly operations to meet instrument, quality, cost, and delivery requirements

Leader of the new product introduction to other members of the manufacturing team that came from the Lancaster, PA plant to Mexico the facility

Provide technical support to the molding department manufacturing high volume, high quality plastic molds

Proficient in AutoCad; Develop the plant lay-out, assembly workstation, machine requirements for the instillation

Create Process documentation for new product introduction like PFMEA, control plan, visual instructions, flow chart, and set up verification, Kanban, autonomous maintenance, and board for KPI.

Implemented and trained the Eight Disciplines (8Ds) Problem Solving methods

GE Health care --- Juarez, Chihuahua Feb 2011 to Nov 2013

Validation/Design Engineer.

Design validations (Validation Master Plan, IQ, OQ, and validation summary report) for new products introduction: create, generate and execute the validation activities for the design outputs of the new products

Led and implement the Engineering change Orders for the Cuff products in the AGILE system

Coordinate and implement the Design Changes on the manufacturing production cells

Implement cost reduction projects for the Cuffs Products with savings above the 800K dollars annually

Providing technical support to Manufacturing Engineers to ensure that product meet the design requirements

Providing Engineering support for the Engineering change request process

Responsible for the completion of all documentation regarding to design projects

Approve and submit test results required to solve Manufacturing issues

Set-up reviewed and processed ECR/ECOs for production release

Ensured Continuous compliance with GMP (Good manufacturing Practice)

Conduct and Document customer complains

Design Test procedures for Verification Purposes

GE Health care --- Juarez, Chihuahua Jan 2010 to Feb 2011

Production Team Leader.

Achieved space reduction of 2340 ft. with a new distribution plan by applying lean manufacturing techniques

Implemented and integrated the philosophies of Lean manufacturing, and Six-sigma, into a manufacturing strategy that led to the cycle time reduction by 20% and increased process capacity and efficiency by 30% and 15% in a time span of two months

Accomplish the daily production plan to track progress of assigned employees

As a leader I understand the importance of training and development of junior engineers

Ensure that all the activities were in complain with QA policy

Coordinate the Electronic/Medical production area in order to reach the production metrics

GE Health care --- Juarez, Chihuahua Jan 2007 to Jan 2010

Manufacturing Engineer

Executed the building transfer of all engineering activities from one facility to another

Lead production transfers into the plant in Juarez, Mexico; execute all the verification tasks required for machines, tools, and facilities to ensure the design requirements by relocating the manufacturing process

Responsible for product support of current cuff product line as well as development, transfer and commercialization of new products from R&D to Manufacturing

Validate and Verification for all new and modified equipment

Reviewed and approved the Manufacturing Visual Aids

Created and released the PFMEA for the Manufacturing process of the products

Ensure that production process was in compliance with the QA requirements

Supported FDA, ISO and Internal Audits of the medical devices in the plant

Electrolux --- Juarez, Chihuahua Apr 2005 to Jan 2007

Manufacturing Engineer

Leader of the new appliances plant start-up in Mexico

Develop plant lay-out, assembly workstation, machine requirements and installation

Develop Tooling and fixtures for production area

Create PFMEA, APQP, and PPAP documentation

RCA Thomson --- Juarez, Chihuahua Jul 1997 to Apr 2005

Process Engineer

Improved process flow to increase efficiency by 15% during her tenure in the company

Each year in the company achieve a yearly 15% cost reduction working with direct and indirect labor forecast

Reduce the lead time by 200%

Contact this candidate