Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Quality Systems Auditor for our Global Headquarters in Naples, Fl. site. The Sr. Quality Systems Auditor will perform Internal Quality System Audits to evaluate and determine conformance to industry standards and regulations pertaining to the development, manufacture, and distribution of medical devices.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Preparing for and performing internal quality audits
• Applying applicable regulations to organizational processes
• Issuing nonconformances and following up on the effectiveness of corrections
• Writing and distributing audit reports
• Travel, as needed
• Track and trend quality audit data
• Analyzes processes and collaborate to identify opportunities for improvements and efficiencies.
• Collaborate with process owners to confirm Arthrex procedures and policies are compliant according to Arthrex Quality Management System requirements.

Education and Experience:

• Bachelor’s degree required
• 5+ years Quality Auditing experience required
• Certified Quality Auditor or Qualified Lead Auditor required

Knowledge:

• Demonstrated knowledge of quality auditing principles. Advanced knowledge of GxP best practices
• Knowledge of process improvement methods (i.e. PDCA, DMAIC)
• Solid knowledge of current international regulations and quality standards for medical devices (ISO 13485, MDSAP, EU MDR)
• Advanced knowledge of GxP best practices

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to listen, understand the information provided, and follow instructions.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

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)

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.