Quality Assurance Specialist III - Apex Systems

Job#: 2040839

Job Description:

Quality Assurance Specialist III
Growing 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.
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 company 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 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 Employer

Apex 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. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.