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.