Staff Quality Engineer - MA Licensed

Job Summary

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