Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. Arthrex is actively searching for a Quality Systems Auditor at our newest manufacturing facility in Pendleton, SC. The successful candidate will have multiple years of auditing experience coupled with a Bachelor’s degree. Excellent attention to detail, problem solving and follow through are a must for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
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.
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.
Benefits Arthrex Offers:
Arthrex pays 100% of employee's medical and dental coverage with voluntary participation in the wellness program. For regular, full-time and part-time employees Arthrex pays 50% of employee's dependent coverage.
The Arthrex Medical Center provides convenient, free care for employees.
Arthrex provides a 401k retirement plan option with matching contributions.
Arthrex encourages professional development with tuition reimbursement toward an undergraduate or graduate degree.
Arthrex Learning & Development department has many opportunities to expand your skills online and in classroom experiences.
Arthrex provides free lunches to save our employees time and money. Plus, it's a great opportunity to enjoy time with your coworkers.
And there is so much more!
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.
Internal Number: 48769
About Arthrex Manufacturing, Inc
Arthrex, a global medical device company and leader in new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.