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Vandalia, Ohio, United States
Onsite
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:
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 Manager, Quality Assurance
The Manager, Quality Assurance is responsible for establishing, administering, and maintaining Quality Assurance (QA) processes, systems, and tasks in compliance with current Good Manufacturing Practice (cGMP), current Good Distribution Practice (cGDP), and applicable domestic and international standards for tissue, biologic, and medical device products. The Manager, Quality Assurance manages quality departments at Axogen’s facilities, including Processing Centers (DPC or APC) or the Burleson Distribution Center (BDC).
The Manager, Quality Assurance collaborates closely with Operations to provide Quality Assurance (QA) support, ensuring that the organization maintains high standards of compliance and fosters a culture of continuous improvement in manufacturing, processing, systems, testing, and product distribution functions. This role is responsible for developing and executing quality strategies that align with company goals and industry best practices. By working cross-functionally, the Manager, Quality Assurance helps implement scalable processes that support organizational growth and ensure quality standards are met for receiving, storage, processing, shipping, and distribution activities.
Requirements of the Manager, Quality Assurance
Responsibilities of the Manager, Quality Assurance
The specific duties of the Manager, Quality Assurance include but are not limited to:
The specific duties of the Manager, Quality Assurance at APC assigned to own Cleanroom Processing and Laboratory Operations include but are not limited to:
The specific duties of the Manager, Quality Assurance at APC assigned to own Drug Product, Facility, and Technical Operations include but are not limited to:
Location
913 Industrial Drive Place, Vandalia, OH 45377
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Benefits/Compensation
This position is eligible for an annual bonus.
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.
Company Statements
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.
As AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen.
No agency solicitation. We kindly request that recruiting agencies, staffing firms, and third‑party vendors do not contact us regarding this posting. Unsolicited résumés will not be considered.