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

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Systems management, ensuring compliance with FDA regulations and ISO standards while leading cross-functional teams in process improvement initiatives. Proficient in data analysis and quality management system software to maintain effective quality management practices.

Highest-signal resume keywords

Quality Management System (QMS) Software ProficiencyFDA Part 1271 ComplianceISO 13485 ComplianceLeadership Experience in Quality or Regulatory AffairsAATB Certified Tissue Bank Specialist (CTBS)

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Data AnalysisProcess Improvement MethodologiesRisk ManagementSampling PlansStatistical TechniquesComplaint HandlingPost-Market SurveillanceNon-conformance ManagementCorrective Action/Preventive Action (CA/PA)Change Management

Soft Skills

Excellent Verbal CommunicationExcellent Written Communication

Tools & Technologies

Microsoft Excel

Certifications & Qualifications

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

Industry Keywords

Quality SystemsRegulatory AffairsDocument ManagementRecord ControlInternal AuditsThird-party AuditsNotified Body InspectionsQuality Management System EffectivenessAccreditationsLicenses

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 quality management system effectiveness
Support stakeholders in executing NC, CA/PA, and audit response actions
Lead cross-functional teams developing audit responses and track response commitments within the CA/PA system
Develop and implement process improvement initiatives within Quality Systems programs
Support company process improvement initiatives affecting Quality Systems
Review and approve quality system documentation for accuracy, consistency, and compliance
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 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 skills
Risk Management knowledge
Process Improvement Methodologies knowledge
Sampling Plans and Statistical techniques knowledge
Data Analysis skills
Minimal travel required
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
Professional development opportunities