Quality Assurance Medical Device

James Post H: 925-***-****

San Ramon, CA ***** *********@*****.***

QA Inspector

Research ● Medical Device ● Fiber Optics ● Hardware ● Defense

Over 20 years experience and education in all aspects of quality assurance needed for a wide range of industries. Applies mechanical aptitude, problem-solving skills, planning and project management experience to meet all production and research requirements.

Works well with suppliers to identify quality problems and work collaboratively to resolve them quickly. Audits processes and production at both company locations and supplier factories. Trained in using a broad range of testing equipment for mechanical, electrical, and vacuum systems. Program and operate Zeiss cmm and Brown & Sharpe cmm .More than 20 yrs experience using GD&T. Also worked in and around machining envirorment for more than 20 yrs.

Coordinates with engineers, scientists, buyers, production managers and personnel. Experienced in following regulatory production and audit requirements for military, FDA, and ISO standards.

Some materials which I have worked with over past 20 yrs include, aluminums, coppers, cast iron, steel, stainless steel, ceramic, beryllium, many different kinds of composite materials, plastics, glass, and many other materials

Career Highlights

Zeltiq, Pleasanton, CA 2009 – 2011

Manufacturer of cosmetic medical devices

Quality Assurance Technician

• Inspects all incoming products for both electrical and mechanical quality.

• Organizes and trains inspection personnel in use of general inspection equipment.

• Programs and operates Zeiss and CMM machines.

• Perform Mechanical inspections using GD&T .

• Works with suppliers to identify and solve quality problems. Performs factory source inspections.

• Performs internal audits of assembly area and processes.

• Calibrates equipment for both external and in-house calibration.

• Worked with many different types of materials and composites materials.

• Performs in-process audits to ensure government compliance with all detailed documentation.

Stanford Linear Accelerator Center, Palo Alto, CA 2002 – 2009

Scientific research in the field of high-energy physics, partially funded by Dept. of Energy

Senior Electro Mechanical Technician

• Built, installed and monitored new high-vacuum systems using diagrams and clean-room specifications provided by scientists.

• Tested systems using electronic and mechanical equipment. Performed Q.A. on all parts before assembly. Reworked parts and processing, including coordination with cleaning, brazing, plating, and other assembly work areas. Perform inspections Using GD&T standards and all standard inspection hand tools. Work in and around machining

• Worked with many different types of materials and composites materials.

Matrika, Sunnyvale, CA Contract 2001 – 2002

Manufacturer of medical device used for diabetes

Quality Assurance Specialist

• Wrote and reviewed E.C.O.’s

• Assessed needs and performed equipment calibrations. Coordinated with outside test labs when required.

• Monitored all environment areas, including refrigeration and clean room.

• Performed in-process audits to ensure government compliance with all detailed documentation.

James Post Page 2

Guidant, Menlo Park, CA Division shut down 1999 – 2001

Manufacturer of medical device stints

Senior Quality Technician

• Inspected all incoming products for electrical and mechanical quality. Wrote and reviewed E.C.O. and coordinated M.R.B. Programmed and operated Zeiss, CMM and Rio View machines.

• Applied understanding of FDA, Ansi-Y-14.5 and ISO 9001, MIL-STD-105e requirements for inspections to remain in regulatory compliance.

• Performed internal audits of assembly area and processes.

• Generated and analyzed quarterly statistics on supplier performance.

SDL, San Jose, CA 1996 – 1999

Manufacturer of fiber optic lasers used for communication

Senior Quality Technician

• Inspected all incoming products for both electrical and mechanical quality.

• Wrote and reviewed E.C.O.’s and coordinated M.R.B. Group.

• Organized and trained inspection personnel in use of general inspection equipment.

• Programmed and operated Brown & Sharpe, CMM, and Rio View machines.

• Worked with suppliers to identify and solve quality problems. Performed factory source inspection. Maintained and reviewed supplier performance data on quarterly basis.

Ataratar Systems, San Jose, CA Company closed 1993 – 1996

Startup company making portable hard drives

Quality Technician

Inspected incoming products and parts, and performed first article inspection. Coordinated M.R.B.

Additional Experience

Acuson, Senior Mechanical Inspector

Westinghouse, Mechanical Inspector

Education & Professional Training

Zeiss CMM Brown & Sharpe

Professional training on equipment programming and usage

GD &T

Training

Varian

Vacuum system training

San Jose State University Bachelor of Science, Industrial Arts

10 units required to complete the degree

De Anza College, Cupertino, CA Associate of Arts, Quality Assurance

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