Manager - Quality Systems Auditing

Requisition ID: 66312

Title: Manager - Quality Systems Auditing

At Arthrex, quality isn’t just compliance—it’s a critical enabler of innovation and patient impact. In this role, you won’t simply manage audits—you’ll shape and evolve a global audit program that drives real business value.

This position offers the opportunity to:

• Lead a high‑visibility, enterprise audit program supporting FDA, ISO 13485, and global regulatory requirements
• Drive risk‑based auditing and data‑driven insights that influence executive decision-making
• Partner cross-functionally to strengthen CAPA, change management, and overall system effectiveness
• Build and develop a high-performing audit team, fostering a culture of accountability and continuous improvement
• Play a key role in ensuring inspection readiness while supporting Arthrex’s rapid growth and innovation pipeline

We are looking for a leader who sees auditing not as a retrospective function, but as a proactive, strategic capability that elevates the entire quality system.

Main Objective: Manage Internal and External Quality System Audit Processes

Essential Duties and Responsibilities:

• Quality Systems Auditing
• Lead and manage the internal audit program in compliance with 21 CFR Part 820, ISO 13485, MDR, MDSAP, and other applicable global regulations.
• Plan, conduct, and report internal audits of quality system processes, ensuring objectivity and adherence to auditing best practices.
• Lead, support, and participate in external audits and inspections (e.g., FDA, Notified Bodies, MDSAP, global regulatory authorities).
• Audit Program Management
• Develop and maintain a risk-based audit program and schedule.
• Ensure timely documentation of audit findings, clear classification of observations, and alignment with regulatory expectations.
• Track audit metrics and effectiveness indicators, reporting trends and risks to management.
• Drive continuous improvement of audit tools, methodologies, and auditor competency.
• Partner with process owners to ensure audit findings are appropriately documented, investigated, and addressed through effective NCR or CAPA.
• Ensure audit records and evidence are inspection-ready and maintained per document control requirements.
• Monitor regulatory changes and assess impact to auditing processes and QMS.
• Serve as a subject matter expert for audit and inspection readiness activities.