Quality Engineer Manufacturing

JOSÉ LUIS ALVARADO

**** *** **** **., ******, California 95368-0357 : Home Phone: 209-***-**** : Mobile Phone: 209-***-****

E-Mail: *************.************@*****.***,

SENIOR MANUFACTURING ENGINEER

CAREER SUMMARIES:

Multifaceted engineer recognized by its dedication, dynamic, self-motivated, and results-oriented with extensive experience servicing in the Medical Device Industry familiarized with nitinol alloy process as laser technology as cutting and engraving, heat treatment, expansion and electro polishing for components as stents and clip appliers, and all kind of material testing as fatigue, corrosion, failure analysis, and material characterization. Broad experience solving quality assurance and quality testing, data analysis, line production, manufacturing, warehouse, maintenance, equipment operation, instrumentation, and calibration issues with outstanding troubleshooting ability. Proven track record of high levels of quality assurance, cost savings, productivity, and overall equipment readiness; committed to quality workmanship and ethical conduct. Adaptable leadership style, cooperative and hands on peers’ requirements and support; promoting and developing teamwork and spirits; flexible schedule and vocational aptitude and attitude. Good verbal and written skills with work autonomy meeting projects milestone and deadlines. Solid educational foundation in, Mechanical, Electrical and Electronics knowledge; supported by college degrees in “Metallurgical” and “Electronics Technology.” Technical skills and experience on manual lathe and mill machining, and CNC programming. Experienced drafting with SolidWorks and Master-Cam, and Quality Assurance in dimensional verification components with Coordinate Measuring Machine (CMM) programming dimensional reports, first article and reverse engineering.

AREAS OF EXPERIENCE:

Personnel Management

Operations Management

Project Management

Procurement

Training and Supervision

Budget Management

Maintenance & Calibration Coordination

Warehouse

Inventories Process and Controls

Expenses

Purchasing

Testing and Sampling

Quality Controls

Suppliers Evaluation

Validation EXECUTING (FAT, SAT, IQ, OQ, PQ)

TECHNICAL SKILLS:

MS Office Suite (Excel, Words, Outlook, PowerPoint, Access)

Fluent in English and Spanish language

Yellow Belt – Lean Six Sigma Quality System

C++ & C++.NET programming

PIC Basic microcontrollers programming

Visual Basic Programming

Assembly Language

SAP

TrackWise

GAGEtrak

PLC programming language (Entry Level)

Laser Technology (Cutting, Engraving)

NITINOL alloy process (mechanical and chemical)

Material characterization

Mechanical Test (fatigue, corrosion, Failure Analysis Mode, Tensile, Compression, Hardness,

Machine Tooling Design

Master-Cam CNC Programming

CMM programmer (Critical Features Report, First Article, Reversed Engineering),

Manual Lathe

Mill machines operation

GD&T ASME Y14.5M-1994,

Solid Works sketching and drafting

Calibration Manager (Blue Mountain)

MP2 (Manufacturing Plant v.2)

CPR and First Aid Trained (ADAMS Certification)

HAZ-MAT Training Certification

LOTO Training Certification

HVAC & Refrigeration

Object Oriented Programming

KEY PROFESSIONAL ACHIEVEMENTS:

+ 25% Savings in Calibration expenses

+ 35% Calibration Inventory Reduction

+ 85% Overtime reduction on Preventative Maintenance

+ 50% Downtime reduction on Demand Maintenance

+ 50% Reduction of Calibration and spare components inventories

+ 50% Savings on calibration expenses

+ Assisted on new “STENT” production line implementation

+ Assisted on ISO 9001-ISO 13485 Certification

+ Implemented reuse recycled and reprocessed sand in green molding process by 15%

+ Implementation of BASIC SKILLS Training Laboratory

WORK EXPERIENCE:

WESTLAND TECHNOLOGIES

507 S RIVERSIDE, MODESTO CA 95354

QUALITY ENGINEER II 2019 - Present

Responsible to maintain and improve the QUALITY System. Recognized for the fast adaptation to the Westland Technologies culture, management system and job core duties.

100%-Dimensional evaluation for in process part (first part evaluation)

100% on time reports for Daily lot acceptance. Creating CMM programs for all manufactured parts, reversed engineering, new customers and demanded dimensional inspections. (physical and soft models)

Creating QA, PMs, SOPs and TIPs for all manufactured parts

Drafting in Solid Works and MasterCam, creating model for the CMM, Re-designing and re-dimensioning drawings and sketches for first customer or contractors

100% calibration completion and implementation for all calibrations item (1500+) instruments

Support Calibration activities for Building Automation Systems (BAS), Air Handler Units (AHU) and Mixing Air Units (MUA), temperature sensor, probes, Magnehelic Gauges (Room Differential Pressure), transmitter and indicators (current and voltage)

AMNEAL PHARMACEUTICALS

(IMPAX Laboratories)

31145 Hayward, CA 94544

Amneal is recognized as the 5th largest generic drug manufacturers once the acquisition of IMPAX Labs. The headquarters are in NY, and the main manufacturing site is in Bridgewater NJ.

CALIBRATION ENGINEER II 2017 - 2019

Responsible to maintain and improve the calibration system. Recognized for the fast adaptation to the IMPAX pharmaceutical culture, management system and job core duties. Management appreciation due to the reduction of the calibration inventory and overtime by 40%. Appreciation for the fast integration to the calibration system for the new added sites.

100% calibrations completion on time

100% on time training completion

Lead and direct 4+ technicians task training, schedules and goals

100% on time and accurate Monthly, Quarterly, Yearly, trending, POs and Capital Projects reports

90% on time completion for SOP, Protocols and Deviations, Test and Calibration Instructions

Manage the calibration scheduler software (GAGEtrak, & SAP)

100% completion on all CAPA investigations and engineering support

Supplier Evaluation

25% Savings on calibration expenses

Supported Calibration activities for Building Automation Systems (BAS), Air Handler Units (AHU) and Mixing Air Units (MUA), temperature sensor, probes, Magnehelic Gauges (Room Differential Pressure), transmitter and indicators (current and voltage)

Supported calibration and maintenance to the Compressed Dry Air System (CDA), pressure gauges, pressure sensor, transmitter (current and voltage), and PLC systems

Supported maintenance with HVAC system, calibrating and installing probes and temperature

Supported maintenance during trouble shooting activities for coaters, compressed units, and granulation systems

Supported maintenance on all electronics and PLC trouble shooting activities for main process systems as Glatt, Coaters, Blenders, Water Purification System

GC MACHINING

3728 IMPERIAL WAY, SUITE E

STOCKTON, CA 95215

GC Machining is a growing business located in Stockton California. They manufacture part for the Aerospatiale, Computer and Electronics Industry just to mention the main customers’ areas.

QUALITY ENGINEER 2016 – 2017

Recognition for the customer service and requirements on dimensional reports. Owner’s appreciation due to the implementation of the new CMM Machine to the daily reports, first article and Critical Features Report. Responsible for the metrology laboratory, schedule calibration, coordinate services and manage laboratory priorities. Recognition for the elaboration of the Test Instruction (TI), Standard Operation Procedures (SOP), Inspection Instruction (II), Laboratory Equipment Maintenance.

100% on time completion for all First Article reports, reverse engineering, and dimensional evaluations for new parts, subcontractors, new customers and customer requested reports. (physical and soft models)

100%-Dimensional evaluation for in process part (first part evaluation)

100% on time reports for Daily lot acceptance. Creating CMM programs for all manufactured parts, reversed engineering, new customers and demanded dimensional inspections. (physical and soft models)

Creating QA, PMs, SOPs and TIPs for all manufactured parts

Drafting in Solid Works and MasterCam, creating model for the CMM, Re-designing and re-dimensioning drawings and sketches for first customer or contractors

100% calibration completion and implementation for all calibrations item (1500+) instruments

Support Calibration activities for Building Automation Systems (BAS), Air Handler Units (AHU) and Mixing Air Units (MUA), temperature sensor, probes, Magnehelic Gauges (Room Differential Pressure), transmitter and indicators (current and voltage)

ABBOTT LABORATORIES (ABBOT VASCULAR Division)

400 SGINAW DR.

REDWOOD CITY, CA 94063

ABBOTT Vascular is a large medical device industry and it is a subsidiary of ABBOTT Laboratories with the Headquarter located in Chicago Il. The ABBOTT Vascular is specialized in the vessel closure devices using and implementing new technology as nitinol in its devices as the “StarClose” and the latest innovation the “Mitraclip”.

METROLOGY ENGINEER 2000 – 2016

MAINTENANCE ENGINEER SUPERVISOR 2008 – 2010

MANUFACTURING ASSOCIATE ENGINEER 2004 – 2008

QUALITY TEST LABORATORY SUPERVISOR 2000 – 2004

Responsible to maintain and improve the calibration system. Management appreciation for the reduction of the calibration inventory and overtime. Management appreciation for the calibration system recovery. Involved in the Lean Six Sigma training (YELLOW Belt recognition). Member of the group of investigation for the nitinol clip applier and delivery system. Assigned to review all nitinol material characterization cards. Awarded with gold and silver recognition for the participation on special CAPA investigation and projects (Coating, Stent Crimper Machine, Packaging Machine, Decommissioning Equipment, etc.)

100% calibrations completion and implementation of the calibration program for 3000+ instruments and 350+ equipment

Lead and directs 14+ technicians’ task, training, schedules and goals

80% completion on all assigned procedures for Calibration Test Instructions and Inspection Procedures

Manage the calibration scheduled software (Blue Mountain, MP2, AMIGO and MAXIMO)

50% Savings in calibration expenses

100% on time and accurate Monthly, Quarterly, Yearly, trending, POs and Capital Projects reports (100K>)

100% completion on all CAPA investigation due to process, instrumentation and equipment unconformities

90% completion on all Project Assignments interaction with R&D and Validation engineering

Implementation of first article reports for New equipment spare parts, new components projects, and Solid Works drafting (add cost savings)

Calibration and maintenance support to the Compressed Dry Air System (CDA), pressure gauges, pressure sensor, transmitter (current and voltage), and PLC systems

Support maintenance with HVAC system, calibrating and installing probes and temperature

Participate in the CAPA investigation for the nitinol material contamination

Participate in the nitinol clip laser cutting inspection

Maintenance support during trouble shooting activities for coaters, compressed units, and granulation systems

Maintenance support on all electronics and PLC trouble shooting activities for main process systems as Glatt, Coaters, Blenders, Water Purification System

GUIDANT Inc.

1305 O’BRIEN DR.

MENLO PARK, CA 94025.

One of the largest manufacturers of cardiovascular products. The headquarter were located in Indianapolis, IN. GUIDANT was officially acquired by Boston Scientific (Pharma Division) and ABBOTT labs (Vascular Division) in 2007.

R&D STENT LABORATORY SUPERVISOR 1999 – 2001

Management recognition for the optimization of resources of the stent process. Responsible for the generation of the equipment maintenance procedures as laser cutting and engravers machines, ovens, fumes extraction chambers and hoods, expansion barrels and other ancillary equipment. Recognized by the fast adapted and familiarization with the stent process as laser technology (cutting, engraving), heat treatment, sand blasting, chemical treatment, expansions, and electro polishing. Participating in the monthly stent production planning meetings to project the capacity and availability of resources based on stents demand by surgeons, destructive test and scrap. Plan and coordinate the laboratory resources for the daily, weekly and monthly stent production. Management appreciation by the implementation of the basic skills training program for the new laboratory technicians.

Implementation of the PM schedule to the main equipment laboratory as Laser cutting and graving machines, ovens, fume extractors and hoods, sand blasting and expansion barrels

Responsible for laser equipment maintenance, operation and software

95% production program completion

100% completion of all Test Instruction (TI) compression, fatigue, tensile

100% completion of all Inspection Instruction (II) for the daily lot acceptance stents

Implementation of the Basic Skills Requirements for the Stent Laboratory Technician

Responsible to review all materials shipments and nitinol material composition card

Involve on new material stent production as SS, Ti, Ni, Cu, Ag, Au.

Participate on the monthly management reports for stent laboratory production program

Assigned to the “STENT TEAM” new production line implementation in the production clean room for large stent quantities under ISO 9001-ISO 13485 Certification

ADDITIONAL RELEVANT EXPERIENCE:

PROCUREMENT ENGINEER GIRSA D.F. MEXICO

MANUFACTURING ENGINEER NISSAN Mexicana, LERMA Edo. Mex. MEXICO

EDUCATION:

2016 Machining Technology Chabot College Hayward, CA

2007 Electronic Technology Engineering DeVry University Fremont, CA

1997 Master’s Degree Administration Management UNAM Mexico City, MEX

1992 Metallurgical Engineering UNAM Mexico City, MEX

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