Design Quality Assurance Engineer- CAPA - Medical Device #1458

Brief Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role

The main responsibilities of the Design Quality Assurance Engineer will include, but are not limited to, providing quality oversight and strategic leadership for design and development activities within the medical device lifecycle. The ideal candidate will ensure compliance with regulatory and quality standards, foster collaboration across R&D, Quality, and Regulatory teams, and drive continuous improvement in design processes and documentation. This role is remote with up to 25% travel required.

What You’ll Do

• 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.

What We Look For

• 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).
• Prior consulting or contract experience in a regulated environment preferred.
• Familiarity with eQMS/PLM tools
• Excellent communication, analytical, and leadership skills.
• ASQ CQE or Six Sigma certification preferred.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. 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. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.