What are the responsibilities and job description for the Quality Specialist position at Axogen?
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
