Quality Systems Auditor

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Quality Systems Auditor to join the Quality Systems Auditing team at our site in Naples, FL. The Quality Systems Auditing team is responsible to audit Arthrex's Quality Management System (QMS) to ensure compliance with all applicable regulatory requirements. Excellent communications and analytical skills, Auditing experience as a quality systems auditor and a Bachelor's degree will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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 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.