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Us_quality Specialist Iii Job In San Jose, California, Talentburst, Inc.

Published 2022-08-04
Expires 2022-09-04
ID #1114527518
Free
Us_quality Specialist Iii Job In San Jose, California, Talentburst, Inc.
United States, California, San Jose,
Published August 4, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: Us_quality specialist iii


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Description

Description:



* Responsible for supporting development and implementation of Quality Management System (QMS) and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and Roche corporate requirements, specifically GCP and CDx support. Support management and maintenance of training assignments for the site. Track, monitor and report site training compliance data. Partner with department managers and trainers to develop/ update training matrices. * Experience in Change management, Supplier qualification, Inspection and CAPA management is an added advantage. Exposure to internal, external, laboratory, supplier auditing programs as appropriate. * Good to have experience in supporting project-related and QMS documentation using Electronic Document Management System (EDMS). Support coordination of document and record retention program for the site in alignment with the Roche corporate requirements.



Skills* 2-4 years related experience in relevant medical diagnostic/device industry, including 1-2 years of direct Quality operations. Experience focused on quality systems, regulatory affairs/compliance or project management. * Familiarity with relevant international ISO Standards (13485, 62304, 14971), and regulations (European medical/in-vitro devices directives, 21 CFR - part 820). * ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus. * Understanding of GCP requirements required.



Education



* Bachelors' degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.

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    Employer's info

    Talentburst, Inc.
    Registered on October 7, 2017

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    Information technology (IT) is the application of computers to store, study, retrieve, transmit, and manipulate data, or information, often in the context of a business or other enterprise. IT is considered a subset of information and communications technology (ICT). In 2012, Zuppo proposed an ICT hierarchy where each hierarchy level "contain[s] some degree of commonality in that they are related to technologies that facilitate the transfer of information and various types of electronically mediated communications". The term is commonly used as a synonym for computers and computer networks, but it also encompasses other information distribution technologies such as television and telephones. Several industries are associated with information technology, including computer hardware, software, electronics, semiconductors, internet, telecom equipment, and e-commerce. Humans have been storing, retrieving, manipulating, and communicating information since the Sumerians in Mesopotamia developed writing in about 3000 BC, but the term information technology in its modern sense first appeared in a 1958 article published in the Harvard Business Review; authors Harold J. Leavitt and Thomas L. Whisler commented that "the new technology does not yet have a single established name. We shall call it information technology (IT)." Their definition consists of three categories: techniques for processing, the application of statistical and mathematical methods to decision-making, and the simulation of higher-order thinking through computer programs.


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