Quality Specialist II
Company
axogen
Location
Other US Location
Type
Full Time
Job Description
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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! Â
Axogen is the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves. Â
Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members!Â
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.Â
 Why you’ll love working at Axogen:Â
- Friendly, open, and fun team culture that values unique perspectivesÂ
- Company-wide dedication to profoundly impacting patients’ livesÂ
- Comprehensive, high-quality benefits package effective on date of hireÂ
- Educational assistance available for all employeesÂ
- Matching 401(k) retirement planÂ
- Flexible working hoursÂ
- Paid holidays, including floating holidays, to be used at your discretionÂ
- Employee Stock Purchase PlanÂ
- Referral incentive programÂ
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/Â
Axogen is hiring for a Quality Specialist II in Alachua, FL!
Job Summary of the Quality Specialist II
The Quality Specialist II 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. Issues, distributes, and updates controlled manuals. Assists in the compilation of regulatory filing documents and maintains computerized files to support all documentation systems. Assists in external and internal quality audits.Â
Requirements of the Quality Specialist II
- 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 with application of risk management processes such as FMEA
- 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.
- CQA accreditation preferred.
- Experience with electronic data management systems preferred.Â
Responsibilities of the Quality Specialist II
The specific duties of the Quality Specialist II include but are not limited to:
Tissue Donor Eligibility Records
- 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. Â
- 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 recordsÂ
Location
13631 Progress Blvd #400, Alachua, FL 32615
#LI-AC1
Benefits/Compensation
This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 2 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Hourly Pay Range
$25.70—$32.13 USD
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
Date Posted
10/11/2024
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