Quality Specialist IV (Medical Devices

Quality Management System Specialist

Duties:

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 Client 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 Client 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). 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.