Manager, Quality Assurance

Role: Manager, Quality Assurance at Axogen, overseeing QA operations for tissue, biologic, and medical device products in compliance with cGMP, cGDP, and international standards. Responsibilities: manage QA teams at processing and distribution centers, develop and maintain QMS, lead internal and external audits (FDA, ISO), ensure regulatory compliance, and drive continuous improvement in manufacturing, processing, and distribution. Specific duties include oversight of cleanroom and facility operations, equipment qualification, environmental monitoring, and computer systems validation. Requirements: Bachelor's degree in Life Science or Engineering, minimum 5 years of QA/Quality Engineering experience in biotech, medical devices, or pharma manufacturing, with at least 3 years of leadership or project management. Experience with regulatory audits, cGMP standards, and statistical analysis is essential. Preferred qualifications include familiarity with Lean Six Sigma, Certified Quality Engineer, and experience managing external audits. High-Value: Focus on tissue, biologic, and medical device manufacturing; regulatory compliance with FDA and international agencies; and GMP-driven quality systems. Work setup: based in Vandalia, OH, with travel up to 10%. The role emphasizes cross-functional collaboration with Operations, Finance, and Quality teams to ensure compliance, quality, and continuous process improvement.