Quality Inspector

Burleson, TX - USA

Monthly Salary: Not Disclosed

Posted on: 20 hours ago

Vacancies: 1 Vacancy

Job Summary

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 youll love working atAxogen:

Friendly openandfunteam culturethat values uniqueperspectives
Company-wide dedicationto profoundly impacting patients lives
Comprehensive high-quality benefitspackage effective on date of hire
Educationalassistanceavailable for all employees
Matching 401(k)retirementplan
Paid holidaysincluding floating holidaysto 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.
Bachelors 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 Axogens 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 Axogens 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.

Hourly Pay Range

$18.40$23 USD

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.

Required Experience: