Quality Systems Engineer

Re:Build Manufacturing(26 days ago)

Wilmington, MAOnsiteFull TimeSenior$110,000 - $140,000Quality Assurance

About this role

The Quality System Engineer will lead and maintain the company's Quality Management System to ensure compliance with ISO 13485 and applicable regulatory standards. This role supports product development-to-manufacturing transitions and collaborates across functions to uphold quality and drive continuous improvement. The position is focused on ensuring regulatory readiness, supporting audits, and delivering measurable QMS performance to leadership.

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Required Skills

Quality Management
Regulatory Compliance
ISO 13485
Continuous Improvement
Design Transfer
Collaboration
Auditing
Training
Metrics Monitoring
CAPA

+3 more

Qualifications

Bachelor's Degree in Engineering
Bachelor's Degree in Life Sciences
CQE
CQA

About Re:Build Manufacturing

rebuildmanufacturing.com

Re:Build Manufacturing is a family of industrial businesses focused on "rekindling American industry." The group operates and invests in manufacturing companies across Aerospace & Defense, Electrification, Energy & Environment, Medical, and Robotics & Intelligent Automation. Re:Build builds and scales advanced domestic production capabilities, combining engineering, automation, and operational expertise to support reshoring, supply‑chain resilience, and commercialization of advanced technologies.