QA Technician

Req # 690P

 

Thoratec Corporation is a leading manufacturer of circulatory support products for use by patients with congestive heart failure.  We sell Ventricular Assist Devices, or VAD?s, to virtually every leading heart transplant center in the world, marketing three out of the four VAD?s approved by the U.S. Food and Drug Administration.  We are also a leading provider of point-of-care blood diagnostic test systems.

 

We have an excellent opportunity for a QA Technician in our Corporate Headquarters located in Pleasanton, California.  This individual performs mechanical inspections to assist in the in-process inspection of production and engineering materials, and ensures documentation is complete and accurate.

DUTIES/RESPONSIBILITIES:
Reviews device history records, manufacturing records and Quality Assurance records to verify that the information is accurate and complete and that all the specifications have been met (4.5).  Ensures that product, at all stages of inspection, maintains proper identification, traceability, and inspection and test status(4.14).  Performs general inspection, in-process, and final inspection of product, packaging and labeling (4.10).  (4.8, 4.12)(4.10)Conducts visual, dimensional and functional inspection, as directed by quality assurance procedures and other specifications.  Performs physical testing such as packaging peel tests; polymer product break load and ultimate elongation.  Ensures measurement, test and inspection equipment is calibrated and in good condition.

 

EDUCATION AND EXPERIENCE:

Requires an AA degree or technical education with a minimum of one year related experience or equivalent combination of education and experience.  Previous experience in the medical device industry preferred.  Must be knowledgeable in using measurement equipment and tools such as calipers, gages, micrometers, etc. and have understanding of basic inspection techniques.  Must be able to read blueprints and schematics.  Proficiency in using basic math skills to obtain test and inspection results.  Experience in or familiarity with regulatory requirements such as FDA GMP, ISO and Quality Systems Regulations.  Must be familiar with current software such as Microsoft Excel, Word, Access, which are used in generating reports and statistics.  Good verbal and written communication skills are important..


No relocation assistance available for this position.

Email your resume and salary requirements to HRJobsCA2@thoratec.com   EOE M/F/D/V.