Senior Quality Systems Auditor

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 Pendleton, South Carolina Manufacturing 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
• Analyza 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. 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.  Good working knowledge of the English language, including proper spelling, grammar, and punctuation. Bi-lingual language skills are a plus (Spanish, German).

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

Vision Requirements:

Visual acuity is necessary to do the job safely and effectively.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.

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.