Design Quality Assurance (CAPA) Engineer - Medical Device #3067

ECI provides professional consulting services and product life cycle solutions for the life sciences industry. The Design Quality Assurance (CAPA) Engineer will provide quality oversight and strategic leadership for medical device design and development, ensuring compliance with regulatory and quality standards. The role will support risk management, design controls, audits, regulatory submissions, CAPA investigations, and continuous improvement initiatives.

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