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Amy Halik is an accomplished Director of Quality at Higi, with extensive experience in quality management systems and regulatory compliance in the medical device sector. Responsibilities include developing and maintaining quality management systems aligned with MDSAP, ISO, and other regulations, managing post-market surveillance, and leading cross-functional teams in quality issue resolution. Additionally, Amy holds a long-standing role as an independent consultant specializing in compliance assurance, auditing, and training on quality systems. Previous roles include Quality Systems Manager at AHIMA, where Amy implemented accreditation standards, and several positions at Baxter Healthcare, where notable achievements in compliance improvement and cost savings were realized. Educational background includes a BS in Biology and Psychology from Elmhurst University.