Senior Quality Systems Auditor

 Requisition ID:                       60557                          Title: Senior Quality Systems Auditor Division: Arthrex Manufacturing Inc (US02) Location: Pendleton, SC

 

 

 

 

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: