Mobile: 408-***-****

acxh07@r.postjobfree.com

Mailing address:

**** ***** *****

San Jose, CA.95127

Cristina J. Javier

Objective

Seeking opportunities in hopes to contribute my skills and abilities to assist the company in reaching the long and short-term goals.

Skills

Strong knowledge in working within a GMP, FDA QSR, and ISO 13485 regulated clean room environment.

In-depth knowledge and extensive experience in the use of microscopes, soldering stations, and other specialty equipment.

Experience in early to mature phase start-up medical device companies.

Proficient with measuring instruments including ROI (RAM Optical Instrument), SmartScope, Calipers, Micrometers, Depth Gages, Pin Gages, Thread Gages, Leak Gages, Tensile Testers (e.g Instron), Coordinate Measuring Machines, Balloon and catheter burst testers and destructive and non-destructive testing techniques.

Experience

VytronUS Inc. Sunnyvale, CA

Quality Technician/Inspector November 2015 – Present

Performed general inspection activities for received materials, in-process, and finished goods.

Used measurement equipment (i.e. optical comparator, calipers, and micrometers) to verify incoming material against material specification drawings and inspection plans.

Maintained inspection records and recorded recording defects identified.

Maintained proper inspection status labeling of process materials.

Assisted in generating Non-Conforming Material Reports

Assured material inspections and dispositions are completed in a timely manner.

Support the VytronUS Quality Policy and Quality System.

Assisted in other duties as assigned by Quality Engineering Manager.

Gemini Interventional Technologies, LLC., Sunnyvale, CA

Quality Technician/Inspector November 2014 – October 2015

Incoming inspection: used documented Quality Inspection instructions (QIs), material specifications, and other supporting documentation to ensure the components are compliant prior to release to inventory.

Performed lot release testing on finished product and document test results.

Assist with other product release activities (e.g packaging review) as necessary to facilitate product release to finished goods inventory.

Performed incoming and final catheter visual inspection to ensure product meets quality inspection requirements.

Facilitated initialization of NCRs by providing supporting information or documenting non-conformance.

Managed Quality related material locations such as material quarantine, QC hold, and pre and post sterile quarantine to ensure that proper material is contained in the appropriate locations.

Performed Document Control activities such as releasing DCO,s scanning and filing quality documents.

Contributes to internal and external audit activities (as required).

AngioScore, Inc., Fremont, CA

Manufacturing Assembly Tech March 2012 – October 2014

Assembled angioplasty balloon catheter used for both coronary and peripheral artery disease.

Knowledge of thermal bonding and UV curing manufacturing processes such as intermediate, distal, and proximal bonding.

Performed shape setting of nitinol scoring element using heat treated process.

Performed incoming and final catheter visual inspection to ensure product meets quality inspection requirements.

Performed leak testing of OEM and finished catheters.

Knowledge of clean room standard of conduct.

Ensure compliance to Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and applicable procedures.

Assisted in the assembly of prototypes and validation

BPV – FlowCardia Technologies Center, Sunnyvale, CA

CER Assembly Tech May 2010 – March 2012

Built MicroSheath guide catheter including lap joint, marker band placement, and hub attachment.

Knob Sub-Assembly; Know and connector cleaning using ultrasonic cleaning.

Mixing SurModic coating solution

Catheter coating, packaging for sterilization, and final labeling and packaging

Performed catheter friction test.

Hotspur Technologies, Mountain View, CA

CER Assembly Tech May 2009 – April 2010

Expert assembler in all assembly stations for 3 products: involving polymer fusing/melting, tip forming, adhesive bonding, extrusion hole punching, catheter shaping, packaging

Performed in-process and final assembly quality inspections

Work with Engineers on resolving line issues and process improvements

WL Gore and Associates, Inc., Sunnyvale, CA

Medical Device Assembly Tech March 2008 – April 2009

Operated specialized machine holding mandrels for winding NiTi wire

Performed rotation inspection of winding work by other operators

Performed annealing of stents

Operated equipment holding mandrels that guides sewing of FEP threads into stents

Performed line clearance in various processes before other associates commence work to ensure compliance of standing work inspection

Sewed of triple-A stents (e.g., contra lateral leg, ipsi lateral leg, iliac extender leg, aortic extender, and trunk stents etc.) using FEP thread and fiber sutures

Attached ipsi leg into trunk stents, as well as various stent components, using tubing and heat box

Cryovascular/Boston Scientific Corp., San Jose, CA

Production Builder II Oct. 2006 – March 2008

Performed laser marking process for lot number and catheter size markings

Used heated die presses to assemble vacuum extension assemblies, Pebax manifold assemblies, and inner balloon assemblies

Performed Guidewires lumen assembly using quick-drying adhesives under a microscope for proper component orientation in the assembly

Utilized UV-cured adhesives to bond inlet connector sub-assemblies for use on the catheter

Used small handle presses to assemble o-rings onto Connector subassemblies.

Performed Boxing of Finished goods Catheters.

Modified Polymer Components, Inc., Sunnyvale, CA

Production Operator July 2005 – Oct. 2006

Operated forming, heating, trimming, and pressurizing machine.

Used inspection tools such as calipers, rulers, pin gauges, and video optical comparators.

Trained new employees to operate various equipment and performed assigned tasks to each station.

Visually inspected in a microscope for product defect.

Experienced on working in a clean room environment

Education

University of Baguio Preparatory High School, Philippines

University of Baguio College, Philippines

Reference

Upon request

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