Staff Quality Engineer - MA Licensed

Staff Quality Engineer - MA Licensed, this full-time contract position involves leading quality engineering initiatives, supporting product development and manufacturing processes, and driving continuous improvement in the quality management system for IVD products. Key Responsibilities Lead quality engineering initiatives and ensure compliance with regulatory requirements for IVD products Conduct audits, manage CAPA processes, and oversee non-conformance investigations to resolve quality issues Collaborate with cross-functional teams to integrate quality requirements into product design and support regulatory submissions Required Qualifications Bachelor's Degree is required 8+ years of experience in Medical Devices design and development, focusing on design control and risk management Experience working in an FDA-regulated environment and with IVD products ASQ Certification and Regulatory Affairs Certification (RAC) are preferred Demonstrated experience applying medical device regulations and quality management systems