Job Description

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.

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
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.