Manager, Quality Assurance

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. F