Quality Systems Supervisor

Evergen•Alachua, FL

7d•Onsite

About The Position

Evergen is hiring a full-time Quality Systems Supervisor to oversee and execute critical Quality Systems programs, including Document Control and Change Management, ensuring compliance with applicable regulations, standards, and company objectives. The role supports quality-system compliance with internal and external regulatory requirements, monitors the regulatory landscape, analyzes and reports quality data, and contributes to process improvement in collaboration with cross-functional stakeholders. The supervisor supports third-party audits, including Notified Body inspections, and serves as a subject matter expert during audits for assigned processes. The role reviews and approves quality-system documentation, delivers process training, coordinates daily team activities, and handles performance management, hiring, scheduling, corrective actions, and other employee-relations matters. It also maintains secure records storage, retrieval, retention, and destruction. The position is onsite in an office environment with an assigned workstation in Alachua, Florida, and requires minimal travel.

Requirements

Associate’s degree.
At least 3 years of experience in quality assurance, systems, regulatory affairs, or other relevant experience in a regulated industry such as tissue, medical device, or pharmaceutical.
At least 2 years of leadership experience.
Excellent verbal and written communication skills.
Microsoft Office suite skills.
Experience with Quality Management System (QMS) software.
Problem-solving methodologies.
Data analysis skills.
Records management skills.

Responsibilities

Oversee and execute critical Quality Systems programs, including Document Control and Change Management, to ensure compliance with applicable regulations, standards, and company objectives.
Support quality-system compliance with internal and external regulatory requirements and maintain awareness of the regulatory landscape.
Collect, analyze, and report data to demonstrate conformity and maintain the effectiveness of the quality management system with a high degree of accuracy.
Support process improvement initiatives that affect quality systems and collaborate with cross-functional stakeholders to ensure processes and procedures comply with the quality management system.
Support third-party audits, including Notified Body inspections, through planning, execution, closeout, and follow-up.
Act as a subject matter expert during internal and third-party audits for responsible processes.
Review and approve quality-system documentation for accuracy, consistency, and compliance.
Deliver training on responsible processes.
Coordinate and lead daily team activities and performance management, hiring, scheduling, corrective actions, and other employee-relations matters.
Maintain the records management system, including secure storage, retrieval, retention, and destruction.
Perform other duties as assigned.