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.

 

Leadership & Collaboration:

• Be the point of contact for establishing the external audit schedule with the Notified Bodies.
• Lead, coach, and mentor internal auditors and audit team members.
• Provide audit-related guidance and training to cross-functional stakeholders.
• Collaborate with Quality Systems, Regulatory Affairs, Manufacturing, R&D, Supplier Quality, and other functions to promote a strong culture of compliance and quality.

 

 

Travel Requirements:

• Occasional domestic and international travel may be required (typically 5–15%).
• Office-based with periodic manufacturing or sister site visits.

 

Education and Experience:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 8+ years of experience in medical device quality, regulatory compliance, or auditing.
• 3+ years of direct auditing experience (internal, supplier, or regulatory).
• Strong working knowledge of:
  • FDA QSR (21 CFR Part 820)
  • ISO 13485
  • MDSAP requirements
  • Global regulatory frameworks
• Proven experience managing audit programs and interacting with regulatory inspectors and Notified Bodies.
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Key Competencies: 

• Strong leadership, communication, and influencing skills.
• High attention to detail with the ability to see systemic issues.
• Ability to assertively challenge noncompliance while maintaining collaborative relationships.
• Excellent organizational and time management skills.
• Sound judgment and independence in decision-making.

 

 

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance