Expanding Innovations · 1 day ago
Quality Engineer - Spinal Devices
United States
Full-time
Remote
Mid Level
4+ years expExpanding Innovations is a leader in non-screw-based expandable cage technologies focused on improving patient outcomes in spinal fusion. They are seeking a highly skilled Quality Engineer to ensure the highest standards of quality and safety in the development of spine surgical devices.
MedicalMedical Device
Responsibilities
Develop inspections and tests to verify product quality at various stages of the manufacturing process
Train quality assurance teams on proper implementation of established inspections
Collaborate with R&D and manufacturing teams to resolve quality issues and implement corrective actions
Evaluate and monitor supplier performance, ensuring adherence to quality standards
Conduct supplier audits and collaborate on continuous improvement initiatives
Collaborate with R&D engineering to review project documents to assure high standards and eliminate opportunities for communication issues with vendors
Develop, implement, and maintain the QMS to ensure compliance with regulatory requirements and industry standards
Conduct internal audits to assess and improve the effectiveness of the QMS
Collaborate with cross-functional teams to identify and mitigate product and process risks
Implement and maintain risk management processes in accordance with industry best practices
Stay abreast of relevant regulations and standards (e.g., FDA, ISO) and ensure the company's compliance with these requirements
Support regulatory submissions and provide documentation for audits
Qualification
Required
Bachelor's degree in engineering or a related field
Minimum of 4 years of experience in a quality role within the medical device industry
Strong knowledge of FDA regulations, ISO standards, and other relevant quality requirements
Experience with risk management processes and techniques
Excellent communication and collaboration skills
Detail-oriented and meticulous, with a commitment to delivering high-quality results
Company
Expanding Innovations
Expanding Innovations to develop and commercialize next-generation technology to improve patient outcomes.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Ron Sacher
Executive Chairman, Co-Founder, Board Member
Recent News
2025-11-13
BioWorld Financial Watch
2025-06-22
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