Vacancy expired!
Our client is looking for Title: Biological Regulatory Quality Assurance Specialist III Candidates should bring-
Bachelors' degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.
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.
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.
Role responsibilities include :
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 COMPANY 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
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
