Quality Specialist

Santa Clara, CA 95050

Posted: 08/31/2018 Employment Type: Contract Industry: Quality & Regulatory Affairs Job Number: 4736

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

 

Duties:             
  • 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.
  • 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 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 GMP and GLP requirements.

 

Education:           

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