James J. Ricos

650-***-****

acxb7h@r.postjobfree.com

OBJECTIVE To obtain a position of challenge where my knowledge and skills will be an

asset to the right team.

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EMPLOYMENT HISTORY / POSITION

08/15-9/16 Capnia Medical Inc

Redwood City, Ca

Senior Quality Technician

Class II F.D.A Medical Device Manufacturing Environment

Incoming Inspection/Final Test Inspection/Calibration Management

Operation of Test Equipment- Instron/Flowmeters/Pressure

Sensors.

08/14-5/15 Asante Solutions

Milpitas, Ca

Senior Quality Technician

Class II F.D.A Medical Device Manufacturing Environment

Worked within a quality team that was responsible for the inspection

of all incoming vendor supplied components that made up My Snap

insulin pump. Inspection of all supporting documents and material

certs to meet FDA requirements. Sampling using C=0 table while

observing established inspection methods per

engineering instructions Optical Comparators, Calipers,

Micrometers, First Article and Final Inspection Smart Scope Automated Vision System. Generation of

Non Conformance Reports,

08/06 - 7/14 Thoratec Corporation

Pleasanton, Ca

Precision Mechanical Inspector II

Class III F.D.A Medical Device Manufacturing Environment Worked within a quality team that was key to the successful launch

of Thoratecs flagship product the Heart Mate II heart assist device.

Responsibilities included the mechanical inspection of close tolerance

specialized components. A thorough inspection of material certs and

vendor supplied reports that accompanied each lot. Sampling using

C=0 sampling plans while observing critical parameters and methods

per engineering instructions. Smart Scope Automated Vision System,

Zeiss CMM, Drop Gage,,Profilometer, Calipers, Digital Micrometers,

Deltronic Pin Gages,Thread Plug Gages, Concentricity Gage, Optical

Comparator,.Dial Test Indicators. Gaging and Variable Inspection.

06/05 – 06/06

Polymer Technology Group L.L.C. Berkeley, CA

Quality Technician: Polymer Manufacturing

Class III Medical Device Manufacturing Environment

Use of Microscopes, Optical Comparator. Visual Inspection of

extruded polymers.

11/97 – 3/01 General Electric. Imatron Div, So. San Francisco, CA

Class II F.D.A Medical Device Manufacturing Environment

QC Inspector III. Inspection of all Incoming Materials, Source

Inspection at Vendor. Calibration Management.

SOPs GMPs

11/89-10/97 Pharmacia Biotech. San Francisco, Ca

Manufacturing Associate II/Quality Control Inspector II

Worked in fast paced machine shop as a Manual and CNC machinist

manufacturing scientific test instruments used in

DNA Sequencing and Forensic Lab Applications. Assisted

Quality Team in attaining ISO 9000 certifications. Worked with

engineers in the development of tooling and fixtures to streamline

manufacturing processes.

7/87-7/89 Applied Dielectrics San Francisco. CA

CNC and Manual machinist. Worked in precision machine shop

fabricating PCB,s for microwave and defense applications.

Duties included registration of artwork layout using microscopes

machining of PCB,s during pre and post manufacturing processes.

EDUCATION / CERTIFICATIONS

Skyline College Associates Degree – June, 2003

Just In Time / Manufacturing Technology Certification, 1992

Geometric Dimensioning & Tolerancing/

An Introduction to the ASME Y14.5M Standard 1995/2009

Tooling U: Quality Systems Overview Certificate Training 2014

Qualifications and Experience

12 Years Experience in Quality Control/ Medical Device production.

Experience with tools and techniques of Quality Control Inspection.

Experience with GMP and ISO 9000 working environments.

Generation of NCR and EC’s.

Experience with MRB procedures.

Aided in the engineering and development of measuring gages and validation fixtures.

Exposure to SPC working environment

All phases of in- process and final inspection.

Excellent communication skills

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