Quality Systems Supervisor

Annual Bonus Opportunity up to $8,000

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN;
Eden Prairie and Glencoe, MN;
Neunkirchen, Germany; and Marton, New Zealand.

Location: On Site, Alachua, FL

We are proud to be Great Place to Work® Certified in 2026
, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.

Our Comprehensive Benefits Package Includes

• Paid Time Off (PTO)
• 401(k) with company match
• Holiday pay
• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• Paid parental leave and much more!

Responsibilities

• Oversees and executes functions within critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives, including, but not limited to, Document Control and Change Management.
• Supports quality system compliance with the appropriate internal and external regulatory requirements and maintain 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 to ensure compliance of processes and procedures within the quality management system.
• Support third-party audits, including Notified Body inspections, through audit planning, execution, closeout, and follow-up with a high level of customer service.
• 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

Education

• Associate’s Degree

Experience

• 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
• A different combination of education and experience may be considered.

Skills

• Excellent verbal and written communication
• Microsoft Office suite
• Quality Management System (QMS) software
• Problem Solving methodologies
• Data Analysis
• Records Management

Travel

• Minimal travel required, may occasionally travel for professional development or to support company initiatives.

Physical Requirement

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

• Onsite:
  Office environment with assigned workstation

Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

• Acc…