Design Quality Assurance (CAPA) Engineer - Medical Device #1458

ECI is hiring a Design Quality Assurance Engineer to provide quality oversight and strategic leadership for medical device design and development activities. The role supports regulatory compliance, design documentation, cross-functional reviews, CAPA activities, and continuous improvement.

Responsibilities:

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
• Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards
• Support Usability Engineering and planning documentation
• Provide independent quality oversight for design and development activities
• Ensure compliance with Design Control requirements per 21 CFR 820.30 and ISO 13485:2016
• Review and approve Design History Files (DHF), Risk Management Files, and associated documentation
• Lead or facilitate cross-functional Design Reviews ensuring traceability and risk alignment
• Evaluate and update design-related procedures, templates, and work instructions
• Support MDSAP, MDR and ISO 14971:2019 compliance activities and audits
• Partner with Regulatory Affairs to ensure design documentation supports regulatory submissions (510(k), CE, etc.)
• Review and approve Verification & Validation (V&V) plans and reports for accuracy and compliance
• Support CAPA investigations, complaint handling, and change control related to product design
• Mentor and train design and engineering teams on quality system and regulatory expectations
• Drive continuous improvement initiatives and contribute to digital QMS / PLM enhancements
• Other ad hoc duties as assigned

Requirements:

• Bachelor's or Master's degree in Engineering, Life Sciences, or Quality Management
• 8+ years of experience in medical device design quality, design assurance, or development quality
• Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, EN62304, MDSAP, and EU MDR/IVDR
• Demonstrated experience managing Design Controls, Risk Management, and DHF maintenance
• Experience supporting Regulatory Submissions (510(k), Technical Files, PMA)
• Familiarity with eQMS/PLM tools
• Excellent communication, analytical, and leadership skills
• At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future
• Prior consulting or contract experience in a regulated environment preferred
• ASQ CQE or Six Sigma certification preferred