Summary

Evergen is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in regenerative medicine solutions. Founded in 1998 and headquartered in Alachua, Florida, the company operates as a strategic partner to Original Equipment Manufacturers (OEMs) across multiple medical specialties including plastic and reconstructive surgery, sports medicine and orthopedics, neuro/spine, and cardiac applications. Evergen distinguishes itself as the only regenerative medicine CDMO offering a comprehensive portfolio of both allograft and xenograft biomaterials at scale, providing customers with unbiased, needs-driven solutions. The company maintains over 280,000 square feet of cutting-edge medical device manufacturing space worldwide, featuring Class 5-7 clean rooms and Class III PMA-ready facilities. With ISO 13485 certification and FDA/USDA registration, Evergen delivers end-to-end services spanning research and development, regulatory support, manufacturing, and supply chain management. The company's patient-first approach focuses on developing customized biomaterial solutions that promote healing, accelerate recovery, and prevent complications, positioning Evergen as a trusted partner in advancing regenerative medicine technologies.

Job description

Responsibilities

Oversees and executes functions within critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives, including Document Control and Change Management.
Supports quality system compliance with internal and external regulatory requirements and maintains awareness of the overall regulatory landscape.
Collects, analyzes, and reports data elements to demonstrate conformity and maintains effectiveness of the quality management system with a high degree of accuracy.
Supports company process improvement initiatives that impact quality systems and works collaboratively with cross-functional stakeholders.
Supports third-party audits, including Notified Body inspections, through audit planning, execution, closeout, and follow-up.
Acts as a subject matter expert during internal and third-party audits for responsible processes.
Reviews and approves quality system documentation for accuracy, consistency and compliance.
Delivers training on responsible processes.
Coordinates and leads daily team activities and performance management, hiring, scheduling, corrective actions, and other employee relations issues.
Maintains records management system including secure storage, retrieval, retention, and destruction.
Other duties as assigned.

Requirements

Associate's Degree
3+ years of experience in quality assurance, systems, regulatory affairs, or other relevant experience within a regulated industry such as tissue, medical device, or pharmaceutical
2+ years of leadership experience
Excellent verbal and written communication
Microsoft Office suite
Quality Management System (QMS) software
Problem Solving methodologies
Data Analysis
Records Management
Minimal travel required

Requirements

Associate's Degree
3+ years of experience in quality assurance, systems, regulatory affairs, or other relevant experience within a regulated industry such as tissue, medical device, or pharmaceutical
2+ years of leadership experience
Excellent verbal and written communication
Microsoft Office suite
Quality Management System (QMS) software
Problem Solving methodologies
Data Analysis
Records Management

Benefits

Paid Time Off
401(k) Matching
Holiday Pay
Medical, Dental & Vision
Short & Long-Term Disability
Paid Parental Leave
Annual Bonus Opportunity

Company overview

Evergen is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in regenerative medicine solutions. Founded in 1998 and headquartered in Alachua, Florida, the company operates as a strategic partner to Original Equipment Manufacturers (OEMs) across multiple medical specialties including plastic and reconstructive surgery, sports medicine and orthopedics, neuro/spine, and cardiac applications. Evergen distinguishes itself as the only regenerative medicine CDMO offering a comprehensive portfolio of both allograft and xenograft biomaterials at scale, providing customers with unbiased, needs-driven solutions. The company maintains over 280,000 square feet of cutting-edge medical device manufacturing space worldwide, featuring Class 5-7 clean rooms and Class III PMA-ready facilities. With ISO 13485 certification and FDA/USDA registration, Evergen delivers end-to-end services spanning research and development, regulatory support, manufacturing, and supply chain management. The company's patient-first approach focuses on developing customized biomaterial solutions that promote healing, accelerate recovery, and prevent complications, positioning Evergen as a trusted partner in advancing regenerative medicine technologies.