Quality Systems Supervisor

Evergen•Alachua, FL

8d•$70,000 - $80,000•Onsite

About The Position

Evergen is hiring a Quality Systems Supervisor for an onsite role in Alachua, Florida. The role oversees and executes critical Quality Systems programs to support compliance with applicable regulations, standards, and company objectives, including Document Control and Change Management. It supports the effectiveness of the quality management system through regulatory awareness, accurate data collection and reporting, process improvement, compliant documentation, training, and records management. The supervisor supports third-party audits and serves as a subject matter expert for responsible processes. The position also coordinates daily team activities and performance management, including hiring, scheduling, corrective actions, and employee relations matters. Minimal travel may be required for professional development or company initiatives. An annual bonus opportunity of up to $8,000 is offered.

Requirements

Associate’s Degree.
At least 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.
At least 2 years of leadership experience.
Excellent verbal and written communication skills.
Proficiency with the Microsoft Office suite.
Experience with Quality Management System (QMS) software.
Knowledge of problem-solving methodologies.
Data analysis skills.
Records management skills.
Ability to move or lift objects up to 25 pounds.
Frequent stationary work (standing or sitting) while utilizing digital displays.
Frequent fine manipulation using hands and fingers.

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 accurately to demonstrate conformity and maintain the effectiveness of the quality management system.
Support process improvement initiatives affecting 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, including hiring, scheduling, corrective actions, and other employee relations issues.
Maintain the records management system, including secure storage, retrieval, retention, and destruction.
Perform other duties as assigned.