Quality Specialist I/II
San Jose Metro Area, 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 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.
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.
Certifications & Licenses:
ASQ Certified Quality Engineer
Certified Quality Engineer