Sobre esta vaga de Manager, Quality Assurance na Axogen
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 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
- Bachelor’s Degree in Life Science or Engineering discipline and/or a related field.
- Minimum of 5 years Quality Engineering/Quality Assurance experience in medical device, pharmaceutical, or biotech manufacturing.
- Minimum 3 years of leading others or project management, direct people management preferred.
- Experience leading external regulatory audits (e.g., FDA, ISO).
- Proficiency in Six Sigma or Lean Manufacturing is desirable.
- Certified Quality Engineer preferred.
- Travel Requirements are up to 10%
- Knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory standards, guidelines, and regulations, both in the US and OUS for tissue, Medical Devices and/or Biologics.
- Knowledge of statistical sampling and analysis.
- Knowledge of Root Cause Analysis (RCA) methodologies.
- Ability to proficiently use MS Office Suite, including Microsoft Smart Sheet, Visio and Project.
- Excellent communication, interpersonal, and team-building skills.
- Strong problem-solving skills and the ability to exercise creativity and judgment.
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve.
Responsibilities of the Manager, Quality Assurance
The specific duties of the Manager, Quality Assurance include but are not limited to:
- Manages Quality Assurance operations at DPC, APC, or BDC, ensuring compliance with domestic and international quality standards for human tissue, biologic, and medical device products.
- Establishes, implements, and maintains Axogen’s Quality Management Systems (QMS) ensuring alignment with
- cGMP, cGDP, QSR, ISO13485, MDD, AATB and other applicable standards.
- Recruits, develops, and manages quality assurance team members, fostering a positive workplace culture and building high-performing team.
- Provides strategic leadership, coaching, guiding performance development, succession planning, and ensuring alignment with company objectives while achieving goals and maintaining regulatory compliance.
- Ensures compliance with FDA, ISO, and other relevant regulatory bodies. Acts as the subject matter expert for tissue, medical device, and biologic regulations.
- Represents Axogen during external audits and inspections. Ensures pre-approval inspection readiness and conducts internal audits and risk assessments.
- Collaborates with Operations, Finance, and Material Handling teams to ensure Quality Assurance support during GMP activities and to meet product demand and regulatory requirements.
- Leads quality planning, verification/validation, and continuous improvement activities.
- Investigates and reduces non-conformances and optimizes inspection processes.
- Determines quality improvement parameters using improvement methodologies relevant to processing activities.
- Performs risk assessments, leads investigations to resolve quality issues, and oversees the qualification and validation activities at distribution and processing sites.
- Trains staff on quality policies and procedures. Facilitates communication regarding changes in facilities, processes, and materials.
- Prepares quality metrics, reports, and presentations by analyzing data and making recommendations to stakeholders.
- Leverages analytical skills, tools and best practices to work across business functions to identify opportunities to do things better, eliminate waste, reduce cost, and find workflow efficiencies; prioritizing opportunities that help achieve strategic imperatives.
The specific duties of the Manager, Quality Assurance at APC assigned to own Cleanroom Processing and Laboratory Operations include but are not limited to:
- Oversight of Avance Starting Material, Drug Substance, and Drug Product Processing processes, including weekly room release, environmental monitoring execution, sample management, gowning for the cleanrooms, process validation, and quarterly dose audits.
- Serves as the quality assurance subject matter expert for computer systems relating to this area, including but not limited to Tulip, laboratory information management systems, and particle monitoring systems.
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:
- Oversight of qualification, maintenance, and calibration activities for equipment, facilities, and utilities; labeling quality review and disposition of drug product, drug product chain of custody, and ancillary systems (including but not limited to: cleaning & sterilization, cleaning solution preparation, and environmental cleaning)
- Serves as the quality assurance subject matter expert for computer systems relating to these areas, including but not limited to maintenance management systems, cleaning & sterilization systems, building monitoring systems, and security access control systems.
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.
