Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!  

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. 

 Why you’ll love working at Axogen: 

Friendly, open, and fun team culture that values unique perspectives  Company-wide dedication to profoundly impacting patients’ lives  Comprehensive, high-quality benefits package effective on date of hire  Educational assistance available for all employees  Matching 401(k) retirement plan  Flexible working hours  Paid holidays, including floating holidays, to be used at your discretion  Employee Stock Purchase Plan  Referral incentive program 

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/ 

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Quality Specialist

The Quality Specialist performs reviews of Tissue Donor Eligibility Records, Production Records and other quality assurance documentation in accordance with US Federal and State regulations and AATB standards. Maintains and updates the document control and tracking databases. Coordinates the review and revision of procedures, specifications and forms. Assists in external and internal quality audits. 

Requirements of the Quality Specialist

Bachelor’s degree in Biomedical Engineering and/ or a related degree preferred  3 years of experience in Tissue Recovery, Donor Eligibility and Tissue Processing  Experience working with Tissue Recovery Agencies and other similar suppliers  Knowledge of quality system regulations and requirements (examples 21 CFR part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971)  Knowledge of American Association of Tissue Banks (AATB) standards  AATB Certified Tissue Bank Specialist preferred.  Experience with electronic data management systems preferred. 

Responsibilities of the Quality Specialist

The specific duties of the Quality Specialist include but are not limited to:

Performs preliminary reviews, including printing and assembling records.  Performs primary reviews.  Interfaces with agencies to ensure documentation is correct and complete. Review agency documentation and Axogen procedures to determine what records are required. Request records as needed. Communicate with agency personnel to resolve any errors, omissions, corrections, or as clarification is needed.  Performs information sharing to inform agencies of tissue disposition  Maintains donor database.  Assists or leads in transition of a paper-based system to an electronic based system for donor records 

Location

13631 Progress Blvd #400, Alachua, FL 32615

#LI-AC1

Benefits/Compensation

Axogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us