Position Role/Tile: Quality Specialist IV
Location: Santa Clara, CA.
* 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 Client corporate requirements.
* Experience in Change management, CAPA and Non-conformance management is an added advantage.
* 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 Client corporate requirements.
- Review and Document test cases
- Perform and document risk analysis
- Record test progress and results
- Review test plans
- Develop standards and procedures to determine product quality and release readiness
- Drive innovation and streamline overall testing processes
- Identify any potential problems that users might encounter
- Research and analyze product features being tested
- Research new tools, technologies, and testing processes
- Review user interfaces for consistency and functionality
* 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.
* Bachelors' degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.
Central Business Solutions, Inc,
37600 Central Ct.
Newark, CA 94560.