Quality Systems Auditor

Arthrex, Inc. is a medical device company and a leader in new product development and education in orthopedics. With locations globally, we strive to work together to give the best to our patients, and in South Carolina that means manufacturing implantable medical devices that change our patients’ lives.

Arthrex continues to experience unprecedented growth and as the newest location in the organization, our corporate mission is Helping Surgeons Treat Their Patients Better™, which we hope to achieve while maintaining opportunity and stability for our employees. Arthrex proudly maintains a family and community business culture and provides all employees with first-class facilities, exceptional benefits, and most importantly, a secure future that recognizes and rewards hard work and dedication.

Main Objective:

Perform Internal Quality System Audits to evaluate and determine conformance to quality system standards pertaining to the development, manufacture, and distribution of medical devices.

Essential Duties and Responsibilities:

• Performing internal audits
• Issuing related corrective actions and following up on effectiveness
• Providing audit reports and trending of related information.
• This role requires travel up to 10-25% of the time.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

• Bachelor’s degree required; preferably in Engineering, Biology, Math, Chemistry or Computer Science.
• 2 years of experience working in a quality system auditing capacity as a quality systems auditor required, preferably with internal or supplier audit experience in a Medical Device Company.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Knowledge of statistical processes and trending preferred.
• Certified Auditor preferred.
• Working knowledge of international standard ISO 13485:2016 for medical devices preferred
• Working knowledge of 21 CFR Part 820, F.D.A. Quality System Regulation
• Familiarity with medical device regulations MDR/MDD for European Union, Japanese MHLW, and Canadian CMDR preferred
• Familiarity with 21 CFR Part 11, FDA Electronic Records / Electronic Signatures preferred

Machine, Tools, and/or Equipment Skills:

PC proficient, ability to use different database applications, strong MS office skills, especially Excel and Power Point. Working knowledge of Pilgrim Smart Solve software as well as SAP and Agile is desired.

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