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.
- Actively participate in quality integration efforts for the Santa Clara site by supporting the planning, implementation and monitoring of integration milestones. Partner with stakeholders to define and implement integration actions.
- Responsible for supporting QMS harmonization effort at the Santa Clara site.
- Write and revise Quality Systems procedures, perform gap assessments and assist in driving compliance. Understanding of laboratory procedures and GLP requirements is a plus.
- Responsible for supporting 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. Partner in defining procedures related to documentation storage and retrieval.
- Support management and maintenance of training program for the site.
- Experience in Change management, Supplier qualification, Inspection and CAPA management is an added advantage. Exposure to internal, external, laboratory, supplier auditing programs as appropriate.
- A proven ability to work creatively and analytically in a problem-solving and process-oriented environment. Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
- A proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives.
- 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.
- Strong interpersonal/communication/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations.
- Bachelors degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.