Hiram Mendoza *** W. San Marcos Blvd. #***

E-mail: abh8ut@r.postjobfree.com San Marcos, Ca. 92069

619-***-****

QA/QC INSPECTOR/TECHNICIAN

Experienced / Efficient / Organized / Knowledgeable of GMPs and SOPs

Highly motivated, quality and detail oriented professional with more than 12 years of experience providing support and

leadership to the manufacturing process in the Medical Device, Pharmaceutical, Packaging and Steel Pipeline Industry.

Resourceful and knowledgeable about the different phases of the production environment. Capable of comprehend and

implement technical guidelines to the quality and production process. Good judgment and common sense. Safety

conscious, good work habits and attendance record. Strong team player with an ethical sense of contribution. Bilingual.

Areas of experience and exposure include:

Quality Control:

Receiving, First Article, In Process, Setup Unit Verification, Visual and Dimensional Inspection, Validation Procedures.

Non-Conformant Material Reports, ECOs, Deviations and CAPAs.

Document Control:

Filing and Organizing Medical Device Records for Medical Device and Spine Product Companies, Creation and

Maintenance of Quality Records including Work Orders, Lot History Records, COs, EOs, Redline and NCMR database,

LHR Review and Reconciliation, Creation of Product Labeling for both Final and In-Process stages of product using

Genesis and LIS Labeling Systems, Compliance Auditor using Viewpoint Software for Document Control, Maintenance

of Calibration Logs and Schedules

ZEST ANCHORS INC.- Escondido, Ca.

Quality Control Technician II. 2008 to 2009.

Managed calibration system, developed part specific programs for SEEBREEZ (non-contact measuring inspection

machine).Performed medical device quality inspections including dimensional, visual and functional. Performed First

Article Inspections for the R&D Department. Contributed to the Gage R&R planning and development. Handled routine

documentation such as travelers, NMR, ECO's etc.

ABBOTT VASCULAR.- Temecula, Ca. .

Quality Control Inspector/Auditor, 2007 to 2008.

Received extensive training in Documentation, Compliance, CER Procedures, SOPs, Quality Standards, STMs, etc.

Became certified Inspector for both Dilatation and DES (Drug Eluting Stents) in less than two months while the majority

of inspectors only hold one certification. Became appointed to train Leads, Supervisors and Inspectors in the

implementation of the Electronic History Record System (LHR) for which I had prior experience. Received the

“Excellence Award” for job performance and professionalism. Trained and certified in the following Software specific for

Medical Device Industry, Gagetalker, LIS (Label ID System), Viewpoint (Document Control), SAP, TRx, CatsWeb

(NCMRs), e-LHR. Performed line audits, product inspection, Material reconciliation, Product Testing, etc.

ALPHATEC SPINE INC. - Carlsbad, Ca. .

Quality Control Lead Inspector. 2005 to 2007

Appointed to become Lead Quality Control Inspector just after three months of employment with the company.

Participated in the development of new and existing Quality procedures. Improved workflow and information

management within the department. Performed Training of new and existing inspectors. Worked with the use of Micro-Vu

vision inspection equipment and software to improve accuracy in dimensional inspection and make the inspection process

more expeditious. Performed Quality Inspection activities for receiving, In Process, R&D, Finished product, By

Prescription only, etc. using Comparators, Micrometers, Calipers, Pin, Thread, Block, Drop, Bore gages, Durometer,

Micro-Vu. etc.

HOWARD LEIGHT INDUSTRIES - San Diego, Ca.

Quality Control Inspector, 2002 to 2005.

Selected to become part of the Quality Assurance Department in the

capacity of Quality Control Inspector.

Trained to perform multiple tasks related to the Department such as

Testing of Products, In Process Inspection, Receiving of Raw Materials,

Control of Quality Records, Control of Non-Conforming Materials,

Preventive and Corrective Action Reporting, Gage Calibration

Measurements.

Received Certification as an ISO 9001 Internal Auditor.

Contributed to the Development, Evaluation and Certification of new

hearing protection products working closely with R&D and Manufacturing

Departments.

GEORGIA PACIFIC CORPORATION - South San Francisco, Ca.

Machine Operator-Inspector, 1995 to 2002.

Served as machine operator-inspector for the largest Corporation in the

Packaging Industry in the US, manufacturing packaging products for some

of its largest accounts.

Rapidly recognized as a competent employee based on performance and

disposition to go above and beyond quality and production standards.

Invited by the General Manager just after six months of employment with

the company to become part of the Process Improvement Team composed of

management, supervisory and production employees.

Broke several production records including one with 80% over previous

record.

Formed part of the Waste Abatement Team.

Became Secretary for the Environmental Impact Team introducing new

procedures for the handling and disposing of hazardous materials.

Maintained good attendance and safety record during the course of my

employment.

ALZA PHARMACEUTICALS - Vacaville, Ca.

Process Operator, In-Process Inspection. 1994 to 1995.

Served in different capacities in the Packaging and OROS departments.

Quickly learned the operation of multiple packaging, labeling, pouching

and cartoning machines.

Contributed to the launching of Nicorette TTS (Transdermal Therapeutic

Systems) to the market in the Packaging department.

Became involved in the documentation process and clean room operation

of drug manufacturing.

Assisted in the production of DUROGESIC both in the extrusion and

Packaging departments.

Suggested and helped with the implementation of new procedures and

practices in the SOPs review board.

NAPA PIPE CORPORATION - Napa, Ca.

Quality Control Inspector, 1993 to 1994.

Assigned and trained in the Steel Oil Pipeline Quality Standards.

Performed rigorous quality checks using different high tech procedures

such as ultrasound analysis, X rays, conductivity, etc.

Enter data on database for quality certification.

THARCO CONTAINERS - San Lorenzo, Ca.

Class I Machine Operator, 1986 to1992.

Started out as floor worker and became the fastest employee to be

promoted to Class I operator in just six months where the normality was

eight years.

Learned to operate all the existing industrial machinery in the plant

from auto, semi-auto, and computer aided manufacturing machinery in

less than a year.

Appointed to receive special training seminars with the ICPF

(International Corrugated Packaging Foundation) to enhance skills.

Broke and set a new record for production with 108, 325 boxes produced

in an eight hour shift where the average production was 35,000.

Received multiple promotions, wage increases and recognition through my

employment with the company.

SPECIAL SKILLS AND TRAINING.

Strong math, Solid General Chemistry, Physics and Computers Skills.

ISO 9001 Audit Certification.

Cleanroom certified auditor.

Extensive Training including but not limited to GMPs, SOPs,

Lockout-Tag out procedures, STOP Safety Training Program, BATC training

for Oil and Chemical plant employees.

Good educational background (Bio-Sciences major).

Spanish 100%, French 75%.

LAB EQUIPMENT:

Micrometers, Calipers, Gages ( Bore, Drop, Thread, Pin, Block, Gap, Surface, Radius, Height, Ball), ÑPC, Electronic

Microscope, Vernier, Ultrasound Probe, Scientific Scale, Laser Mike, PH Meter, Zahn Cup, Bar Code Scanner,

Comparator, Humidity Chamber, Instron Pull Test, Acoustic Measuring Chamber. Rockwell Hardness Tester, Basic CMM

Probe Measuring Machine, Micro-Vu and SEEBREZ non contact measuring systems, Optical Comparator with

Metrology Software, etc.

SOFTWARE:

Excel, MS Word, Outlook, etc.

EQUIPMENT AND MACHINERY OPERATED.

Flexo- Folder Gluers: Martin, Piemonte Mecanicca, Langston IV 3 color

D/C Press, Staley Rotary D/C.

Avery Pouch counter-labeler, Uhlman Cartoner, Piemonte Cartoning

Unitizer, Signode Platen Strapper, Signode Unitizer-Palletizer,

Laminators, Foil-Plastic Load Wrapper, Electric Floor Jack.

PERSONAL REFERENCES:

Star Simkins 760-***-**** Previous Quality Manager known her for 2 years.

Al Grande 951-***-****. Friend and Co-worker, known him for 5 years.

Tony Castro 760-***-**** Friend and Co’worker known him for 2 years..

Mark Needham 619-***-**** Friend, known him for 4 years.

Contact this candidate