This job is posted on behalf of Gallin Associates by Top Echelon.
CLIENT CANNOT SPONSOR/TRANSFER WORK VISA AUTHORIZATION
Manage site-wide Quality Systems programs and team responsible for driving quality activity and compliance including managing audits, document control, NC/CAPA and post-market surveillance activity.
REQUIREMENTS
Bachelor's degree in life sciences or related field preferred
10+ years' experience in a regulated industry, preferably Medical Devices or Pharma
5+ years in Quality or Regulatory Affairs
3+ years managing staff
Experience with FDA Part 820, Part 1271, ISO 13485, or AATB standards
Experienced in supporting NC/CAPA and audit responses
Numbers & Facts
Location
Gainesville, FL
Skills
Auditingunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Document Controlunmatched
FDA (Food and Drug Administration)unmatched
ISO (International Organization for Standardization)unmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
People Managementunmatched
Quality Managementunmatched
Regulationsunmatched
Surveillanceunmatched
Systems Administration/Managementunmatched
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