Quality Inspector jobs in United States
cer-icon
Apply on Employer Site
company-logo

axogen · 11 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
check
Culture & Values
check
H1B Sponsor Likelynote

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

ANSI/ASQ Z1.4-2003FDA regulationsBiologics experienceERP systemsQMS systemsCalipers usageAttention to detailCollaborationDocumentation Practices

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

twittertwittertwitter
company-logo
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 Company
Total Funding
$255.92M
Key Investors
PDL Biopharma
2026-01-23Post Ipo Equity· $124M
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M

Leadership Team

leader-logo
Michael Dale
President and Chief Executive Officer
linkedin
leader-logo
Marc Began
Executive Vice President, General Counsel
linkedin

Recent News

BioWorld Financial Watch
BioWorld Financial Watch
Company data provided by crunchbase