Quality Inspector

Axogen•Burleson, TX

12d•$18 - $23•Onsite

About The Position

The Quality Inspector ensures products meet established quality standards and regulatory requirements. The role involves performing detailed product inspections of Biologics, Medical, and Tissue products and materials using ANZI standard and measuring methods, evaluating compliance and determining appropriate dispositions for non-conforming items. The inspector is responsible for accurately piking biologic product for shipping and distribution in accordance with handling and safety protocols. Responsible for ensuring all policies and procedures are in compliance with applicable FDA, state OSHA and ISO regs and standards.

Requirements

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%.

Nice To Haves

Bachelor’s Degree in a Life Science and/or in a related field preferred.

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.