CLIENT CANNOT SPONSOR/TRANSFER WORK VISA AUTHORIZATION
Job Summary: Lead corporate-wide Quality Systems programs, driving compliance with applicable regulatory standards while managing audits, document control, and continuous improvement across the quality management system.
REQUIREMENTS
Bachelor's degree in life sciences or related field preferred
5+ years in Quality or Regulatory Affairs
3+ years leading teams
Experience with FDA Part 820, Part 1271, ISO 13485, or AATB standards
Experienced in supporting NC/CAPA and audit responses
Experienced driving process improvement initiatives
Strong communicator with QMS software and process improvement skills
Numbers & Facts
Location
Gainesville, FL
Skills
Auditingunmatched
Biologyunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Document Controlunmatched
FDA (Food and Drug Administration)unmatched
ISO (International Organization for Standardization)unmatched
Maintain Complianceunmatched
Process Improvementunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Systems Administration/Managementunmatched
Team Lead/Managerunmatched
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