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Axogen is committed to building and maintaining a strong and gratifying company culture that fosters 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!
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.
Why you’ll love working at Axogen:
- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients’ lives
- 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
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Quality Inspector
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 picking 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 of the Quality Inspector
- High school diploma or equivalent required.
- Bachelor’s Degree in a Life Science and/or in a related field preferred.
- Able to work 10-6:30pm 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 a regulated environment, preferably FDA - particularly Biologics, Pharmaceuticals, Medical Device or Human tissue.
- Working knowledge using ERP and QMS systems.
- Ability to travel 10%.
Responsibilities of the Quality Inspector
The specific duties of the Quality Inspector include but are not limited to:
- 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.
Location
300 Boone Road, Burleson, TX 76028
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Benefits/Compensation
Benefits offered for this position include Health, Dental, Vision, Matching 401K, 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, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
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.
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