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Scientific. Clinical. Engineering

Quality Specialist III

San Jose Metro Area, CA

Employment Type: Full-Time Job Type: Scientific Job Number: JN -082022-30714 Region: San Jose Metro Area

Job Description

Position Summary:

Cutting edge Pharmaceutical company is in search of Quality Specialist III.


Responsibilities:

  • 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 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).

Requirements:

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