axogen · 8 hours ago
Quality Inspector
Axogen is committed to building a strong company culture that fosters professional growth. The Quality Inspector ensures products meet established quality standards and regulatory requirements through detailed inspections of Biologics, Medical, and Tissue products, while also ensuring compliance with applicable regulations.
BiotechnologyMedicalMedical Device
Responsibilities
Responsible for order fulfillment of biologic product by picking applicable product(s) per order and ensuring product against invoice to ensure 100% accuracy
Performs the Quality Inspection of Return Merchandise Authorization (RMA) process
Performs the Quality Release of labeling for all product families
Performs product disposition as per deviation and/or complaint investigation outcome
Support end-to-end inventory by supporting and/or performing inventory scans for all product lines
Performs Quality Assurance activities at Axogen’s Distribution Center. Inspector will be responsible for receiving inspections, in-process inspections and finished product inspections. Products included are Medical Devices, sterile processed Human Tissue-Based Products, components, supplies and labels
Inspectors will maintain Quality Records for the Distribution Center in an “audit ready” state. Records will be precisely organized and quickly retrievable, records will be accurate, complete and free of errors. Inspector will be responsible for ensuring records meet Good Documentation Practices
Ensures work is completed productively and effectively both independently and with other departments
Collaborates with internal customers to understand priorities in daily job activities
Understands and collaborates with management teams to ensure compliance of all requirements of Axogen’s Quality Management System, FDA Regulations and various domestic and international standards. Axogen complies with many external regulations and standards, such as ISO 13485, CFR 1171/1172/ 210/211, AATB (Association for Advancing Tissue and Biologics) and NABP (National Association of Boards of Pharmacy)
Supports external and internal audits
Qualification
Required
High school diploma or equivalent required
Able to work 10-630pm CST, Monday - Friday
Minimum of 3 years of experience in the field or a related area
Familiarity with ANSI/ASQ Z1.4-2003/AQL inspections and use of precise measurement tools such as calipers
Experience working in an FDA-regulated environment, particularly Biologics, pharmaceutical environment, medical device or human tissue
Working knowledge using ERP and QMS systems
Ability to travel 10%
Preferred
Bachelor's Degree in a Life Science and/or in a related field preferred
Benefits
Comprehensive, high-quality benefits package effective on date of hire
Educational assistance available for all employees
Matching 401(k) retirement plan
Paid holidays, including floating holidays, to be used at your discretion
Employee Stock Purchase Plan
Referral incentive program
Health, Dental, Vision
Paid Time Off
9 Paid Holidays + 3 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
Disability Insurance
Company
axogen
AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.
H1B Sponsorship
axogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$255.92MKey Investors
PDL Biopharma
2026-01-23Post Ipo Equity· $124M
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M
Leadership Team
Recent News
BioWorld Financial Watch
2026-01-25
legacy.thefly.com
2026-01-23
BioWorld Financial Watch
2026-01-23
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