Quality Assurance Specialist III

Quality Assurance Specialist IIIGrowing medical diagnostics company in Santa Clara is expanding their team. Apply your skills and grow your career with our tenured, professional team while helping patients achieve better outcomes! This is a hybrid role.Responsibilities:Support 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 company corporate requirements.Experience in Change management, CAPA and Non-conformance management is an added advantage.Support 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.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.Skills: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) is a plus.ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus.Understanding of GMP and GLP requirements.Education:Bachelors degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

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