Quality Systems Manager

Evergen (Formerly RTI Surgical)

. Oversee critical Quality Systems programs to ensure compliance with applicable regulations, standards, and company objectives .

Posted 10/14/2026full-timeAlachua • Florida • United StatesMid-LevelSenior💰 $115,000 - $135,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) and regulatory compliance, with a strong focus on process improvement and data analysis. Proven leadership in managing cross-functional teams and executing quality assurance initiatives.

Highest-signal resume keywords

Quality Management System (QMS) ProficiencyRegulatory Affairs ExperienceLeadership ExperienceAATB Certified Tissue Bank Specialist (CTBS)Process Improvement Methodology Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data AnalysisRisk ManagementSampling PlansStatistical TechniquesComplaint HandlingPost-Market SurveillanceNon-Conformance ManagementCorrective Action/Preventive Action (CA/PA)Change ManagementDocument Management

Soft Skills

Excellent Verbal CommunicationExcellent Written Communication

Tools & Technologies

Quality Management System (QMS) SoftwareMicrosoft ExcelMicrosoft Office Suite

Certifications & Qualifications

AATB Certified Tissue Bank Specialist (CTBS)Process Improvement Methodology Certification

Industry Keywords

FDA Part 1271FDA Part 820ISO 13485AATB StandardsInternal AuditsThird-Party AuditsNotified Body Inspections

About the role

Key responsibilities & impact

Oversee critical Quality Systems programs to ensure compliance with applicable regulations, standards, and company objectives
Manage Complaint Handling and Post-Market Surveillance activities
Lead internal and third-party audits, including Notified Body inspections
Maintain quality and regulatory registrations, licenses, accreditations, and certifications, including notifications
Oversee Document Management and Record Control
Manage non-conformance (NC), Corrective Action/Preventive Action (CA/PA), and Change Management programs
Collect, analyze, and report data to demonstrate conformity and maintain QMS effectiveness
Support stakeholders in executing NC, CA/PA, and audit response actions
Lead cross-functional teams developing audit responses and track commitments within the CA/PA system
Develop and implement process improvement initiatives within Quality Systems programs
Collaborate with cross-functional stakeholders to ensure process and procedure compliance
Review and approve quality system documentation
Lead the Quality System team through recruiting, onboarding, training, career development, and performance feedback
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree in a life sciences discipline or related field
5+ years of experience in a Quality or Regulatory Affairs
3+ years of leadership experience
0–3 years of experience managing quality systems requiring compliance with FDA Part 1271, FDA Part 820, ISO 13485, or AATB Standards
AATB Certified Tissue Bank Specialist (CTBS), preferred
Process Improvement Methodology certification, preferred
Excellent verbal and written communication
Quality Management System (QMS) software proficiency
Advanced Microsoft Excel and Microsoft Office Suite proficiency
Risk Management
Process Improvement Methodologies
Sampling Plans and Statistical techniques
Data Analysis
Minimal travel required; may occasionally travel for professional development or company initiatives
Ability to move or lift objects up to 25 pounds
Frequent (>75%) stationary position while utilizing digital displays
Frequent (>75%) fine manipulation using hands and fingers

Benefits

Comp & perks

Annual CIP bonus opportunity of up to $15,000.00
Paid Time Off (PTO)
401(k) with up to a 6% company match
Holiday pay
Medical, dental, and vision insurance
Short-term and long-term disability coverage
Paid parental leave
Great Place to Work® Certified workplace culture