Senior Manager, Quality Assurance - Auburn, MA

Job description

This role will be on a hybrid schedule at our office in Auburn, MA - expectation is 3 days/ week in the office. Why you will love this role: - Lead quality where it matters most—with real ownership, visibility, and influence at the site level - Drive meaningful impact on patient safety, customer trust, and global business performance - Tackle complex, high‑impact challenges across CAPA, audits, analytics, and continuous improvement - Partner with senior leaders and global teams—your expertise will shape decisions - Build and inspire a strong Quality team while advancing your own leadership career - If you’re ready to move beyond compliance and set the standard for quality excellence, this role is built for you. What you’ll do: - Lead Quality Assurance, Quality Engineering, and Quality Support teams - Own site QMS compliance to FDA, ISO, MDR, CE, and global regulatory standards - Oversee CAPA, complaints, audits, management review, and quality metrics - Serve as Site Management Representative for audits and inspections - Drive continuous improvement through data analytics and quality best practices - Develop talent, training programs, and a strong quality culture What you bring: - 1...