Medical Device Quality Assurance

************@*****.** 408-***-****

Carol Gonzalez

Process Technician: A dynamic technician with over 15 years of result oriented experience in

the medical device / electronics industry. Extensive experience supporting engineering in the

R&D Environment. Strengths & Skills include:

• Prototype Development / Microscope & Soldering / Use of Autoclave and

decontaminating solutions / Use of hand held tools, tweezers, pliers, calipers, OHM

meters / Various RTV,s epoxy’s, loctites

• Testing – HiPot,Leakage Test systems / Spot Welding / Employee Training / Inspector

of Quality / Bilingual - Spanish Language

• SAP / AGILE Data Entry – Inventory Control / Kitting of components

Professional Experience:

Pivot Medical: Sunnyvale, Ca 2012 - 2012

Assembler/Technician: Building minimally invasive Hip Surgery Instruments from start

to finish product. We kitted all are material prior to the build. Loctites and Epoxy’s used on

some instruments. All builds done in a clean room environment. Some rework was performed

on defective instruments. Use of Microscope and hand held tools. I performed the Inspection,

Labeling, Pouching, Boxing of all instruments. Worked closely with engineering on

prototype instruments.

Arthrocare: Sunnyvale, Ca 2009 – 2011

RMA Quality Assurance Technician II: Perform failure investigation of returned / used

Medical Device from the field. Initiate folders for each Device complaint. Decontaminate

returned / used Medical Device prior to investigation. Maintain Device complaint files in

AGILE / SAP system. Maintain and archive quality control records. Provide daily and

weekly updates on returned Device. Keep lab clean and scrap & discard complaint Medical

Device into appropriate receptacles. Interact with engineering on Device investigation.

Participates in internal ISO / GMP audits.

Siemens Medical Solutions, Mountain View, Ca 1988-2008

• Provide technical support to engineering for development and build of Cardiology

Transducers, Catheters, and Tran esophageal Probe flexible Endoscope.

• Worked in a controlled environment. Microscopic & Soldering Experience.

• Inspection of outgoing products to the customer. All time and effort was given to ensure

customer satisfaction with on time delivery of product.

• Review new ECO engineering change orders and releases. Use of SAP and Agile for data

entry.

• Perform daily cycle count of material. Gold standard device ran on electrical test

equipment (Hipot / Leakage). Trained fellow employees to assemble, test, troubleshoot

and repair product.

Education: Spanish Interpreter, Medical/Legal Terminology, Merced City College, 2004

Professional Training: ISO 9000, Chemical Safety Training, OSHA, Safety Policy &

Procedures

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