Quality Systems Manager
About The Position
Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN; Eden Prairie and Glencoe, MN; Neunkirchen, Germany; Glasgow, UK; and Marton, New Zealand. We are proud to be Great Place to Work® Certified in 2026, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.
Requirements
- 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 that require compliance with FDA Part 1271, FDA Part 820, ISO 13485 or AATB Standards
- Additional experience may be considered in lieu of education requirement
- Excellent verbal and written communication
- Quality Management System (QMS) software
- Microsoft Office Suite, advanced Excel
- Risk Management
- Process Improvement Methodologies
- Sampling Plans and Statistical techniques
- Data Analysis
- Move or lift objects up to 25 pounds
- Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
- Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Nice To Haves
- AATB Certified Tissue Bank Specialist (CTBS), preferred
- Process Improvement Methodology certification, preferred
Responsibilities
- Oversees critical Quality Systems programs to ensure compliance with applicable regulations, standards and company objectives including: Complaint Handling and Post-Market Surveillance activities; Internal and third-party audits; Maintenance of quality and regulatory registrations, licenses, accreditations, and certifications, including notifications; Document Management and Record Control; Non-conformance (NC) and Corrective Action/Preventive Action (CA/PA); Change Management
- Collects, analyzes, and reports data elements to demonstrate conformity and maintain effectiveness of the quality management system
- Supports and provides guidance to stakeholders in execution of NC, CA/PA, and audit response actions
- Manages staff members in leading and participating in third-party audits including Notified Body inspections, leads cross-functional teams to support the development of responses, and tracks response commitments within the CA/PA system
- Develops and implements process improvement initiatives within Quality Systems programs to increase efficiency and reduce complexity
- Supports company process improvement initiatives that impact Quality Systems and works collaboratively with cross-functional stakeholders to ensure compliance of processes and procedures within the quality management system
- Reviews and approves quality system documentation for accuracy, consistency and compliance
- Leads the Quality System team by recruiting, onboarding, training, developing career growth opportunities, and giving effective performance feedback
- Other duties as assigned
Benefits
- 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
- Annual CIP bonus opportunity of up to $15,000.00
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
